Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- CDNUrease, Photometric, Urea Nitrogen2Product Code
- CDOAcid, Uric, Uricase (U.V.)1Product Code
- CDPRadioimmunoassay, Total Triiodothyronine2Product Code
- CDEChromatographic Separation/Zimmerman, 17-Ketosteroids1Product Code
- CHARadioimmunoassay, Corticosterone1Product Code
- CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin1Product Code
- CDGChromatography Separation/Zimmerman 17-Ketogenic Steroids1Product Code
- CDHAcid, Uric, Phosphotungstate Reduction1Product Code
- CDKAcid, Vanilmandelic, Electrophoretic Separation1Product Code
- CDLBerthelot Indophenol, Urea Nitrogen2Product Code
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)1Product Code
- CCYZimmerman (Spectrophotometric), 17-Ketosteroids1Product Code
- CCZZimmerman/Norymberski, 17-Ketogenic Steroids1Product Code
- CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin1Product Code
- CDBPorter Silber Hydrazone, 17-Hydroxycorticosteroids1Product Code
- CDCL-Leucyl B-Naphthylamide, Leucine Aminopeptidase1Product Code
- CDDRadioassay, Vitamin B122Product Code
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen2Product Code
- CDR1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine1Product Code
- CDSElectrode, Ion Specific, Urea Nitrogen2Product Code
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides1Product Code
- CDWDiacetyl-Monoxime, Urea Nitrogen2Product Code
- CDXRadioimmunoassay, Total Thyroxine2Product Code
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone1Product Code
- CEATlc Chromatographic Separation Triglycerides1Product Code
- CECRadioimmunoassay, Free Thyroxine2Product Code
- CED5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase1Product Code
- CEERadioimmunoassay, Thyroxine-Binding Globulin2Product Code
- CEFElectrophoretic, Protein Fractionation1Product Code
- CEIUranyl Acetate/Zinc Acetate, Sodium2Product Code
- CEJTetraphenyl Borate, Colorimetry, Potassium2Product Code
- CEKBiuret (Colorimetric), Total Protein2Product Code
- CELAmmonium Molybdate And Ammonium Vanadate, Phospholipids1Product Code
- CEMElectrode, Ion Specific, Potassium2Product Code
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)1Product Code
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus1Product Code
- CEPRadioimmunoassay, Luteinizing Hormone1Product Code
- CEQMolybdenum Blue Method, Phospholipids1Product Code
- CER2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase2Product Code
- CESChromogenesis, Phenylketones (Urinary, Non-Quant.)1Product Code
- CETOlive Oil Emulsion (Turbidimetric), Lipase1Product Code
- CEWRadioimmunoassay, Parathyroid Hormone2Product Code
- CEXChromatographic Separation, Lactate Dehydrogenase Isoenzymes2Product Code
- CFAElectrode, Ion Specific, Magnesium1Product Code
- CFBChromatographic Derivative, Total Lipids1Product Code
- CFDSulfophosphovanillin, Colorimetry, Total Lipids1Product Code
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes2Product Code
- CFGOil Emulsion/Thymolphthalein (Titrimetric), Lipase1Product Code
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase2Product Code
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase2Product Code
- CFLRadioimmunoassay, Human Growth Hormone1Product Code
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)1Product Code
- CFOTitrimetric, Magnesium1Product Code
- CFPRadioimmunoassay, Immunoreactive Insulin1Product Code
- CFRHexokinase, Glucose2Product Code
- CFTRadioimmunoassay, Prolactin (Lactogen)1Product Code
- CFWCopper Reduction, Glucose2Product Code
- CGAGlucose Oxidase, Glucose2Product Code
- CGCRadioimmunoassay, Gastrin1Product Code
- CGDFerricyanide, Glucose2Product Code
- CGEOrthotoluidine, Glucose2Product Code
- CGFRadioimmunoassay, Estrone1Product Code
- CGHElectrophoretic, Globulin1Product Code
- CGIRadioimmunoassay, Estriol1Product Code
- CGJRadioimmunoassay, Follicle-Stimulating Hormone1Product Code
- CGLElectrode, Ion Based, Enzymatic, Creatinine2Product Code
- CGNAcid, Folic, Radioimmunoassay2Product Code
- CGOLieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol1Product Code
- CGRRadioimmunoassay, Cortisol2Product Code
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes2Product Code
- CGTRadioimmunoassay, Cyclic Gmp2Product Code
- CGXAlkaline Picrate, Colorimetry, Creatinine2Product Code
- CGZElectrode, Ion-Specific, Chloride2Product Code
- CHCTitrimetric Permanganate And Bromophenol Blue, Calcium2Product Code
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol1Product Code
- CHERadioimmunoassay, Corticoids1Product Code
- CHGAcid, Phosphoric-Tungstic (Spectrophotometric), Chloride2Product Code
- CHHEnzymatic Esterase--Oxidase, Cholesterol1Product Code
- CHILipase-Esterase, Enzymatic, Photometric, Lipase1Product Code
- CHJMercuric Thiocyanate, Colorimetry, Chloride2Product Code
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride2Product Code
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph2Product Code
- CHMRadioimmunoassay, Total Estrogens In Pregnancy1Product Code
- CHORadioimmunoassay, Cyclic Amp2Product Code
- CHPRadioimmunoassay, Estradiol1Product Code
- CHQChromatographic/Fluorometric Method, Catecholamines1Product Code
- CHRTitrimetric Phenol Red, Carbon-Dioxide2Product Code
- CHSCoulometric Method, Carbon-Dioxide2Product Code
- CHTElectrophoretic Method, Catecholamines1Product Code
- CHWTitrimetric With Edta And Indicator, Calcium2Product Code
- CHZDi (O-Hydroxyphenylimine) Ethane, Calcium2Product Code
- CIAMethylthymol Blue, Calcium2Product Code
- CIBRadioimmunoassay, Angiotensin I And Renin2Product Code
- CICCresolphthalein Complexone, Calcium2Product Code
- CIDAlizarin Sulfonate, Calcium2Product Code
- CIEVolumetric/Manometric, Carbon-Dioxide2Product Code
- CIFVanillin Pyruvate, Ast/Sgot2Product Code
- CIGDiazo Colorimetry, Bilirubin2Product Code
- CIJSaccharogenic, Amylase2Product Code
- CIKRadial Diffusion, Amylase2Product Code
- CILCresol Red Colorimetry, Carbon-Dioxide2Product Code
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes2Product Code
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CIQDiazo, Ast/Sgot2Product Code
- CISHydrazone Colorimetry, Ast/Sgot2Product Code
- CITNadh Oxidation/Nad Reduction, Ast/Sgot2Product Code
- CIWStarch-Dye Bound Polymer, Amylase2Product Code
- CIXBromcresol Green Dye-Binding, Albumin2Product Code
- CIYRadioimmunoassay, Androsterone1Product Code
- CIZRadioimmunoassay, Androstenedione1Product Code
- CJAAmyloclastic, Amylase2Product Code
- CJBChromatographic Separation/Radioimmunoassay, Aldosterone2Product Code
- CJCFructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase1Product Code
- CJDNitrosalicylate Reduction, Amylase2Product Code
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJFTetrabromophenolphthalein, Albumin2Product Code
- CJGTetrabromo-M-Cresolsulfonphthalein, Albumin2Product Code
- CJHThymol Blue Monophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJIDisodium Phenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJJDiazo, Alt/Sgpt1Product Code
- CJKPhenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJLBeta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJMRadioimmunoassay, Aldosterone2Product Code
- CJNAcid Phosphatase, Nitrophenylphosphate2Product Code
- CJOAlpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CJQRadial Immunodiffusion, Albumin2Product Code
- CJRAcid Phosphatase, Thymol Blue Monophosphate2Product Code
- CJTHydrazone Colorimetry, Aldolase1Product Code
- CJWBromcresol Purple Dye-Binding, Albumin2Product Code
- CJXAcid Phosphatase, Disodium Phenylphosphate2Product Code
- CJYAzo Dye, Calcium2Product Code
- CJZAcid, Hydroxyazobenzene-Benzoic, Albumin2Product Code
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt1Product Code
- CKBAcid Phosphatase, Naphthyl Phosphate2Product Code
- CKCVanillin Pyruvate, Alt/Sgpt1Product Code
- CKDHydrazone Colorimetry, Alt/Sgpt1Product Code
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate2Product Code
- CKFPhenylphosphate, Alkaline Phosphatase Or Isoenzymes2Product Code
- CKGRadioimmunoassay, Acth2Product Code
- CKHAcid Phosphatase, Beta Glycerophosphate2Product Code
- DHASystem, Test, Human Chorionic Gonadotropin2Product Code
- GIMTubes, Vacuum Sample, With Anticoagulant2Product Code
- GJETray, Blood Collection2Product Code
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited2Product Code
- JFJCatalytic Methods, Amylase2Product Code
- JFLPh Rate Measurement, Carbon-Dioxide2Product Code
- JFMEnzymatic Method, Bilirubin2Product Code
- JFNAtomic Absorption, Calcium2Product Code
- JFOFluorometric, Calcium2Product Code
- JFPElectrode, Ion Specific, Calcium2Product Code
- JFSCoulometric, Chloride2Product Code
- JFTFluorometric, Cortisol2Product Code
- JFYEnzymatic Method, Creatinine2Product Code
- JGCTryptophan Measurement (Colorimetric), Globulin1Product Code
- JGDNephelometric Method, Globulin1Product Code
- JGETurbidimetric Method, Globulin1Product Code
- JGFDifferential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes2Product Code
- JGGL-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase1Product Code
- JGIAtomic Absorption, Magnesium1Product Code
- JGJPhotometric Method, Magnesium1Product Code
- JGKFerric Chloride, Phenylketones (Urinary, Non-Quant.)1Product Code
- JGMFlame Photometry, Potassium2Product Code
- JGPLowry (Colorimetric), Total Protein2Product Code
- JGQTurbidimetric, Total Protein2Product Code
- JGRRefractometric, Total Protein2Product Code
- JGSElectrode, Ion Specific, Sodium2Product Code
- JGTFlame Photometry, Sodium2Product Code
- JGWFluorometric Method, Triglycerides1Product Code
- JGXTurbidimetric Method, Triglycerides1Product Code
- JGYColorimetric Method, Triglycerides1Product Code
- JGZO-Phthalaldehyde, Urea Nitrogen2Product Code
- JHAAcid, Uric, Uricase (Gasometric)1Product Code
- JHCAcid, Uric, Uricase (Oxygen Rate)1Product Code
- JHDFluorometric Method, 17-Hydroxycorticosteroids1Product Code
- JHERadioassay, 17-Hydroxycorticosteroids1Product Code
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHGChromatographic Separation, Lecithin/Sphingomyelin Ratio2Product Code
- JHHElectrophoretic Method, Lecithin/Sphingomyelin Ratio2Product Code
- JHIVisual, Pregnancy Hcg, Prescription Use2Product Code
- JHJAgglutination Method, Human Chorionic Gonadotropin2Product Code
- JHLMicrodensitometry Method, Lipoproteins1Product Code
- JHMColorimetric Method, Lipoproteins1Product Code
- JHNTurbidimetric Method, Lipoproteins1Product Code
- JHOElectrophoretic Separation, Lipoproteins1Product Code
- JHPRadial Immunodiffusion, Lipoproteins1Product Code
- JHQNephelometric Method, Lipoproteins1Product Code
- JHSDifferential Rate Kinetic Method, Cpk Or Isoenzymes2Product Code
- JHTChromatographic Separation, Cpk Isoenzymes2Product Code
- JHWU.V. Method, Cpk Isoenzymes2Product Code
- JHXFluorometric Method, Cpk Or Isoenzymes2Product Code
- JHYColorimetric Method, Cpk Or Isoenzymes2Product Code
- JIAEnzymatic Methods, Galactose1Product Code
- JIBU.V. Method, Galactose1Product Code
- JICColorimetric Method, Galactose1Product Code
- JIDPhotometric Method, Ammonia1Product Code
- JIEMethod, Ion-Exchange, Ammonia1Product Code
- JIFEnzymatic Method, Ammonia1Product Code
- JIGElectrode, Ion-Specific Method, Ammonia1Product Code
- JIJWet Ash Method, Protein-Bound Iodine1Product Code
- JIKDry Ash Method, Protein-Bound Iodine1Product Code
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)2Product Code
- JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)2Product Code
- JINNitroprusside, Ketones (Urinary, Non-Quant.)1Product Code
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)1Product Code
- JISCalibrator, Primary2Product Code
- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
- JIYPhotometric Method, Iron (Non-Heme)1Product Code
- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
- JJARadio-Labeled Iron Method, Iron (Non-Heme)1Product Code
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)1Product Code
- JJRElectrolyte Controls (Assayed And Unassayed)1Product Code
- JJSControls For Blood-Gases, (Assayed And Unassayed)1Product Code
- JJTEnzyme Controls (Assayed And Unassayed)1Product Code
- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
- K162530Multichem IA Plus1Cleared 510(K)
- K163629Audit MicroControls Linearity FD Tumor Markers II1Cleared 510(K)
- K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak1Cleared 510(K)
- K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit1Cleared 510(K)
- K150300Liquichek Cardiac Markers Plus Control LT1Cleared 510(K)
- K142964VALIDATE Anemia Calibration Verification/ Linearity Test Kit1Cleared 510(K)
- K143379Liquichek Maternal Serum II Control1Cleared 510(K)
- K143573Audit MicroControls Linearity FD Tumor Markers II1Cleared 510(K)
- K140971LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.1Cleared 510(K)
- K142978Audit MicroControls Linearity LQ Special Diabetes1Cleared 510(K)
- K133676ABX PENTRA MICRO ALB CONTROL L/H1Cleared 510(K)
- K141073LIQUICHEK TUMOR MARKER CONTROL1Cleared 510(K)
- K140522RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL1Cleared 510(K)
- K140916LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK1Cleared 510(K)
- K140764LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK1Cleared 510(K)
- K134013LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO1Cleared 510(K)
- K140393RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 31Cleared 510(K)
- K133960LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL1Cleared 510(K)
- K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY1Cleared 510(K)
- K132156RANDOX CSF CONTROLS LEVELS 2 AND 31Cleared 510(K)
- K132751MULTICHEM S PLUS / S PLUS (ASSAYED)1Cleared 510(K)
- K131993MULTICHEM U1Cleared 510(K)
- K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROL1Cleared 510(K)
- K131992MULTICHEM P1Cleared 510(K)
- K132091MULTICHEM IA AND IA PLUS1Cleared 510(K)
- K131595EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM1Cleared 510(K)
- K130337RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 31Cleared 510(K)
- K130963LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK1Cleared 510(K)
- K130762AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET1Cleared 510(K)
- K124009MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C1Cleared 510(K)
- K130761LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK1Cleared 510(K)
- K123725FASTPACK CONTROL KIT1Cleared 510(K)
- K130162LIQUID ASSAYED MULTIQUAL PREMIUM1Cleared 510(K)
- K123775LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK1Cleared 510(K)
- K123663LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK1Cleared 510(K)
- K123198LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA1Cleared 510(K)
- K121603RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 31Cleared 510(K)
- K122838LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK1Cleared 510(K)
- K113720RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 31Cleared 510(K)
- K122291THERMO SCIENTIFIC MAS OMNI-CARDIO1Cleared 510(K)
- K121759CONE-TROL LIQUID CHEMISTRY CONTROLS1Cleared 510(K)
- K121794LIQUICHEK URINE CHEMISTRY CONTROL1Cleared 510(K)
- K121468EUROTROL GAS-ISE METABOLITES1Cleared 510(K)
- K112742AUDIT MICROLQ SPINAL FLUID CONTROL1Cleared 510(K)
- K111964AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY1Cleared 510(K)
- K112705AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL1Cleared 510(K)
- K110534RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 31Cleared 510(K)
- K112337RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL1Cleared 510(K)
- K101863IT/IF CONTROL1Cleared 510(K)
- K110738THERMO SCIENTIFIC MAS OMNI-CORE1Cleared 510(K)
- K110904RANDOX LIQUID URINE CONTROL LEVELS 2 AND 31Cleared 510(K)
- K111996ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 21Cleared 510(K)
- K111506ELECSYS PRECICONTROL VARIA 31Cleared 510(K)
- K110880VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT1Cleared 510(K)
- K110616THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO1Cleared 510(K)
- K111063VITAL SERUM CONTROLS1Cleared 510(K)
- K103601AUDIT MICROCV IMMUNOASSAY LINEARITY SET1Cleared 510(K)
- K103364MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL1Cleared 510(K)
- K103271MSC LIPID CONTROL1Cleared 510(K)
- K101216AUDIT MICROCV PROTEIN LINEARITY SET1Cleared 510(K)
- K102617AUDIT MICROCV CARDIAC MARKERS LINEARITY SET1Cleared 510(K)
- K102700LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS1Cleared 510(K)
- K101809FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-201Cleared 510(K)
- K100727LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK1Cleared 510(K)
- K100718AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-51Cleared 510(K)
- K102016PRECICONTROL CLINCHEM MULTI 1 AND 21Cleared 510(K)
- K101226AUDIT MICROCV RF/CRP LINEARITY SET1Cleared 510(K)
- K102157ELECSYS PRECICONTROL MULTIMARKER1Cleared 510(K)
- K101633NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH1Cleared 510(K)
- K093492MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR1Cleared 510(K)
- K093384MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)1Cleared 510(K)
- K093032TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET1Cleared 510(K)
- K092320ELECSYS PRECICONTROL THYROAB1Cleared 510(K)
- K092051THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M51581Cleared 510(K)
- K090541ELECSYS PRECICONTROL UNIVERSAL1Cleared 510(K)
- K091225VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET1Cleared 510(K)
- K083554CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 31Cleared 510(K)
- K090475VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 4021Cleared 510(K)
- K083891VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 9011Cleared 510(K)
- K082714AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-51Cleared 510(K)
- K082717AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-51Cleared 510(K)
- K082107CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 21Cleared 510(K)
- K082036LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK1Cleared 510(K)
- K082067MSC LIPID CONTROL1Cleared 510(K)
- K080973CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC1Cleared 510(K)
- K073080QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 9451Cleared 510(K)
- K072835LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK1Cleared 510(K)
- K072892TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 51Cleared 510(K)
- K072246VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 6011Cleared 510(K)
- K071980DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H1Cleared 510(K)
- K071675LIQUICHEK TUMOR MARKER CONTROL1Cleared 510(K)
- K071433SMS GLUCOSE CONTROL, MODEL 21200591Cleared 510(K)
- K070741CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 31Cleared 510(K)
- K070504AMMONIA/ALCOHOL CONTROL SET1Cleared 510(K)
- K070200TDM CONTROL SET, MODEL CAT# 045215361Cleared 510(K)
- K070223AUDIT MICROCV LIPIDS LINEARITY SET (LOW)1Cleared 510(K)
- K062379COBAS INTEGRA CERULOPLASMIN1Cleared 510(K)
- K062674MISSION TRINITY B1Cleared 510(K)
- K062593CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET1Cleared 510(K)
- K062916CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &31Cleared 510(K)
- K062668AUDIT MICROCV IMMUNOASSAY LINEARITY SET1Cleared 510(K)
- K061137ADVIA IMS CPSA CONTROL1Cleared 510(K)
- K061196CARDIOIMMUNE XL CARDIAC MARKER CONTROL1Cleared 510(K)
- K060850NOD CHEMISTRY CONTROL1Cleared 510(K)
- K061182CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB1Cleared 510(K)
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- K040379RANDOX IMMUNOASSAY CONTROL1Cleared 510(K)
- K041227MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA1Cleared 510(K)
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- K040925NORMAL AND HYPERGAMMA CONTROL SERUM1Cleared 510(K)
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- K040280PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS1Cleared 510(K)
- K040277LIQUICHEK CARDIAC MARKER CONTROL LT1Cleared 510(K)
- K040273LYPHOCHEK ASSAYED CHEMISTRY CONTROL1Cleared 510(K)
- K040091LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS1Cleared 510(K)
- K033344LIGAND PLUS CONTROL LEVEL 1-31Cleared 510(K)
- K033937ELECSYS PRECICONTROL MULTIANALYTE1Cleared 510(K)
- K033379BAYER SPECIAL CHEMISTRY CONTROLS1Cleared 510(K)
- K033387QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 9451Cleared 510(K)
- K032074LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS1Cleared 510(K)
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- K031921LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A - E FOR BECKMAN COULTER SYNCHRON SYSTEMS1Cleared 510(K)
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- K031575LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS1Cleared 510(K)
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- K030088TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS1Cleared 510(K)
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- K023250LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER IMMAGE1Cleared 510(K)
- K022936LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER IMMAGE1Cleared 510(K)
- K022885LINICAL PROTEIN 4 CALIBRATION VERIFIERS LEVELS-A-E FOR BECKMAN COULTER IMMAGE1Cleared 510(K)
- K022867LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A - E FOR THE BECKMAN-COULTER IMMAGE1Cleared 510(K)
- K022851PH AND AMINES EXTERNAL CONTROL SET1Cleared 510(K)
- K022991LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593; LEVEL 1, 2, AND 3-3 ML, MODEL 594, 595, 5961Cleared 510(K)
- K022591RANDOX LIPID CONTROL1Cleared 510(K)
- K022401PTS PANELS MULTI-CHEMISTRY CONTROLS1Cleared 510(K)
- K022041LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 5631Cleared 510(K)
- K021930MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL1Cleared 510(K)
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- K020237IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 31Cleared 510(K)
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- K012468MODIFICATION TO N/T PROTEIN CONTROL SL1Cleared 510(K)
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- K012431COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,31Cleared 510(K)
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- K012118VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 100021Cleared 510(K)
- K012117VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 100011Cleared 510(K)
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- K002174DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND31Cleared 510(K)
- K002196LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 4831Cleared 510(K)
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- K000875ASSAYED QCS 1,2, CAT. NOS. 970200, 9705001Cleared 510(K)
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- K990149ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-011Cleared 510(K)
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- K990017ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-101Cleared 510(K)
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- K984225LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 3841Cleared 510(K)
- K984074ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-051Cleared 510(K)
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- K983130LIQUID IMMUNOLOGY CONTROLS FOR IMMUNOTURBIDIMETRIC ASSAYS1Cleared 510(K)
- K983166ELECSYS CALCHECK MYOGLOBIN1Cleared 510(K)
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- K982473TUMOR MARKER CONTROL1Cleared 510(K)
- K982290CHEM-CHEX STAT (NEW)1Cleared 510(K)
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- K981455THIRD GENERATION PSA CONTROL MODULE1Cleared 510(K)
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- K981474CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)1Cleared 510(K)
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- K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL1Cleared 510(K)
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- K974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL1Cleared 510(K)
- K974826BM PRECIPATH(R) HDL/LDL-C CONTROL1Cleared 510(K)
- K974827TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R) MYOGLOBIN CALIBRATION VERIFICATION CONTROLS, TRIAGE1Cleared 510(K)
- K974452VIGIL LIPID CONTROL1Cleared 510(K)
- K974384ELECSYS CALCHECK FOLATE1Cleared 510(K)
- K973894IMMUSURE1Cleared 510(K)
- K973791ABC CALIBRATION VERIFIERS1Cleared 510(K)
- K973790ABC LINEARITY VERIFIERS1Cleared 510(K)
- K973629PRECINORM RF, PRECIPATH RF1Cleared 510(K)
- K973517VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS1Cleared 510(K)
- K973469QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS1Cleared 510(K)
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- K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL1Cleared 510(K)
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- K972048ACCURUN 117 HBEAG POSITIVE CONTROL1Cleared 510(K)
- K971657ACCURUN 121 HAV IGM POSITIVE CONTROL1Cleared 510(K)
- K972307ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL1Cleared 510(K)
- K971406ACCURUN 120 HAV IGG POSITIVE CONTROL1Cleared 510(K)
- K972608RANDOX ASSAYED SPECIFIC PROTEIN CONTROL1Cleared 510(K)
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- K971405SPECIALITY URINE 1,21Cleared 510(K)
- K971954LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398)1Cleared 510(K)
- K971071LIQUID LIGAND 1,2,31Cleared 510(K)
- K970956CERTAIN COMPLETE LEVELS 1,2, AND 3; CVM LEVELS 1,2,3,4, AND 51Cleared 510(K)
- K970862SPINALSCOPICS1Cleared 510(K)
- K970979LIQUID CSF(LCR)1, LIQUID CSF(LCR)21Cleared 510(K)
- K970976CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 31Cleared 510(K)
- K965114TUMOR MARKER CONTROL1Cleared 510(K)
- K970147ELECSYS CALCHECK PROLACTIN1Cleared 510(K)
- K965048VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)1Cleared 510(K)
- K965171LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426)1Cleared 510(K)
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- K964065N/T PROTEIN CONTROL SL1Cleared 510(K)
- K961941LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,3631Cleared 510(K)
- K961359LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 21Cleared 510(K)
- K963346STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 31Cleared 510(K)
- K962982NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT1Cleared 510(K)
- K962997NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 31Cleared 510(K)
- K961912QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET1Cleared 510(K)
- K962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL1Cleared 510(K)
- K962575ELECSYS PRECICONTROL CARDIAC1Cleared 510(K)
- K961750DOCUMENT CARDIAC ASSAYED CONTROL1Cleared 510(K)
- K961195CHEM-CHEX STAT1Cleared 510(K)
- K961293QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 21Cleared 510(K)
- K955691SERUM VOLATILES CONTROL LEVEL 1 & 21Cleared 510(K)
- K955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 31Cleared 510(K)
- K960824IMMUNOLOGY CONTROL1Cleared 510(K)
- K960862LIPID CONTROL1Cleared 510(K)
- K955812SYSCON TURMOR MARKER CONTROL1Cleared 510(K)
- K955858N/T PROTEIN CONTROL SY/L, M AND H1Cleared 510(K)
- K954247SYSCON CONTROL ASSAYED & UNASSAYED1Cleared 510(K)
- K955264NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 21Cleared 510(K)
- K955260NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION1Cleared 510(K)
- K955252NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 41Cleared 510(K)
- K954655ROCHE CONTROL SERUM N1Cleared 510(K)
- K954656ROCHE CONTROL SERUM P1Cleared 510(K)
- K955024LIQUICHEK ETHANOL/AMMONIA CONTROL1Cleared 510(K)
- K954323MAS LIQUID URINALYSIS CONTROL1Cleared 510(K)
- K954298VIROTROL IV1Cleared 510(K)
- K954074AALTO SCIENTIFIC LIQUID CARDIAC CONTROL1Cleared 510(K)
- K952385HEMA-TROL Q-CHECK1Cleared 510(K)
- K952877CSF LIQUID CEREBROSPINAL FLUID CONTROL1Cleared 510(K)
- K942647COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI1Cleared 510(K)
- K950802LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM1Cleared 510(K)
- K943394PROSTAT CONTROL1Cleared 510(K)
- K945651LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 31Cleared 510(K)
- K951749BIO-LIPID LIPID CONTROL- LEVEL 1,2 AND 31Cleared 510(K)
- K951170VIGIL MULTICHEK CONTROLS1Cleared 510(K)
- K950469DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K944728BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL1Cleared 510(K)
- K944525LIQUID ASSAYED TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 31Cleared 510(K)
- K950326KENLOR HUMAN SPINAL FLUID CONTROL1Cleared 510(K)
- K942458PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED1Cleared 510(K)
- K950399RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL1Cleared 510(K)
- K946049LIQUISPEX(TM) LIQUID B2M/CRP CONTROL LEVEL 1 AND 21Cleared 510(K)
- K944455QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)1Cleared 510(K)
- K944454QUANITITATE GBCC VERIFIER SET1Cleared 510(K)
- K943729DYE CHECK STRIPS 545-6301Cleared 510(K)
- K945315DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL1Cleared 510(K)
- K944513LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E1Cleared 510(K)
- K944486LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E1Cleared 510(K)
- K944452QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)1Cleared 510(K)
- K944059PROCHEQ 1 & 21Cleared 510(K)
- K935599HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 31Cleared 510(K)
- K942295VIROTROL TORCH1Cleared 510(K)
- K936245MULTI ANALYTE LINEARITY SET1Cleared 510(K)
- K943754BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT1Cleared 510(K)
- K943290BILIRUBIN PLUS/PEDIATRIC CONTROLS1Cleared 510(K)
- K941328TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 21Cleared 510(K)
- K941876WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 21Cleared 510(K)
- K941698SERUM VOLATILES CONTROL - LEVELS 1 AND 21Cleared 510(K)
- K941115ACS CARDIO-TROL CONTROL1Cleared 510(K)
- K941912N/T PROTEIN CONTROL SY/L, M, AND H1Cleared 510(K)
- K936184VIGIL PRX CHEMISTRY CONTROL1Cleared 510(K)
- K930534TMC I, II1Cleared 510(K)
- K935219FERTILITY PLUS 1, 2, 31Cleared 510(K)
- K940397ACS O DILVENT PROTEIN DILUTION MATRIX1Cleared 510(K)
- K933844PARA 4 PLUS1Cleared 510(K)
- K933437DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 31Cleared 510(K)
- K934357LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 21Cleared 510(K)
- K934056TRI-POINT BRAND LIQUIMMUNE IMMUNOASSAY CONTR 1,2 & 31Cleared 510(K)
- K933435DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 21Cleared 510(K)
- K930850BECKMAN VIGIL PLUS CONTROL1Cleared 510(K)
- K933317LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 21Cleared 510(K)
- K924919DADE(R) TUMOR MARKER CONTROL1Cleared 510(K)
- K931366TRI-POINT LIQUIMMUNE IMMUONASSAY CONTROL, L-1,2,31Cleared 510(K)
- K932458DOCUMENT ENZYME1Cleared 510(K)
- K932076LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II1Cleared 510(K)
- K923663MULTITROL IMMUNOLOGY CONTROL1Cleared 510(K)
- K931373ANALYZER: STAT PROFILE PLUS 10 ANALYZER1Cleared 510(K)
- K931139DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET1Cleared 510(K)
- K925326ELECTROPHORESIS CONTROL LEVEL 11Cleared 510(K)
- K924802CALIBRATION VERIFICATION KIT OR CVK1Cleared 510(K)
- K925256QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL1Cleared 510(K)
- K924061CANCER ANTIGEN CONTROL1Cleared 510(K)
- K926046DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III1Cleared 510(K)
- K924915SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#14791Cleared 510(K)
- K923795DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET1Cleared 510(K)
- K921477I-STAT(TM) LEVELS 1,2,3 CONTROLS1Cleared 510(K)
- K923633MULTIQUAL ASSAY PRODUCTS1Cleared 510(K)
- K923632MULTIQUAL UNASSAYED PRODUCTS1Cleared 510(K)
- K923740KODAK AMERLITE TOTAL THYROID CONTROL SERA1Cleared 510(K)
- K920291MONI-TROL-L AND MONI-TROL-XL1Cleared 510(K)
- K923165AMERLITE FREE THYROID CONTROL SERA LAN.40021Cleared 510(K)
- K922046LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 31Cleared 510(K)
- K920636DADE URINE CHEMISTRY CONTROL LEVELS I AND II1Cleared 510(K)
- K920927KEMTROL SERUM CONTROL-NORMAL CAT NO. 70241Cleared 510(K)
- K921286LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 21Cleared 510(K)
- K920926KEMTROL SERUM CONTROL-ABNORMAL1Cleared 510(K)
- K920940AMERLITE FREE THYROID CONTROL SERA LAN.40021Cleared 510(K)
- K920826HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL1Cleared 510(K)
- K920350CHEM-CHEM MULTI-ANALYTE (MODIFIED)1Cleared 510(K)
- K914958RIATRAC PLUS1Cleared 510(K)
- K914204TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,31Cleared 510(K)
- K914890N/T PROTEIN CONTROL UY1Cleared 510(K)
- K914255LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&21Cleared 510(K)
- K915191RAI-TROL ELEVATED LIPIDS CONTROL1Cleared 510(K)
- K914619CVM1Cleared 510(K)
- K913133CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)1Cleared 510(K)
- K913224LIPID LINEARITY CONTROLS1Cleared 510(K)
- K913687CHEM-CHEX1Cleared 510(K)
- K912718ENZYME LINEARITY CONTROL1Cleared 510(K)
- K912455DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL1Cleared 510(K)
- K912725TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL1Cleared 510(K)
- K912441LINEARITY TEST KITS1Cleared 510(K)
- K911984ANEMIA I, II1Cleared 510(K)
- K911854DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL1Cleared 510(K)
- K911755CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE1Cleared 510(K)
- K911803HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED1Cleared 510(K)
- K910440DOCUMENT REFLECTANCE II LINEARITY TEST SET1Cleared 510(K)
- K911171ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III1Cleared 510(K)
- K911169ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I1Cleared 510(K)
- K904989CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II1Cleared 510(K)
- K905389CHEM-CHEX LIPID1Cleared 510(K)
- K904784CHOLESTECH L.D.X. LEVEL 1 CONTROL1Cleared 510(K)
- K904781CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL1Cleared 510(K)
- K904872HDL CHOLESTEROL CONTROL1Cleared 510(K)
- K902740LDL-DIRECT CONTROLS1Cleared 510(K)
- K904968QCLYTE PROTEIN BASED ISE CONTROL1Cleared 510(K)
- K904829ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL1Cleared 510(K)
- K904075CLINICAL CHEMISTRY CONTROL1Cleared 510(K)
- K904768KODATROL I AND II CONTROL AND DILUENT SET1Cleared 510(K)
- K904141TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III1Cleared 510(K)
- K904099URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS1Cleared 510(K)
- K904293HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237)1Cleared 510(K)
- K903933DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&21Cleared 510(K)
- K903566DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III1Cleared 510(K)
- K903407AFFINITY HLH TEST SYSTEM1Cleared 510(K)
- K903338KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL1Cleared 510(K)
- K903310CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR1Cleared 510(K)
- K902909CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL1Cleared 510(K)
- K903225CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT1Cleared 510(K)
- K903190MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY1Cleared 510(K)
- K902616BILIRUBIN CONTROL1Cleared 510(K)
- K902094BLOOD GAS/ISE CONTROLS1Cleared 510(K)
- K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND1Cleared 510(K)
- K902235LVM QUALITY CONTROL SERUM1Cleared 510(K)
- K902573PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM1Cleared 510(K)
- K902536PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM1Cleared 510(K)
- K902095BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS1Cleared 510(K)
- K901988DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET1Cleared 510(K)
- K901212LIG/TDM A, B, C1Cleared 510(K)
- K900717TECHNICON TESTPOINT(TM) LIGAND CONTROL1Cleared 510(K)
- K901115MULTICONSTITUENT SERUM RANGE LINEARITY #882341Cleared 510(K)
- K900993CHEM-CHEX1Cleared 510(K)
- K892642DADE(R) TDM CONTROL1Cleared 510(K)
- K895862CLP NORMAL LIPID CONTROL1Cleared 510(K)
- K895905LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,31Cleared 510(K)
- K896247CLP COMPREHENSIVE LIPID CONTROL-HR1Cleared 510(K)
- K896246CLP COMPREHENSIVE LIPID CONTROL-LR1Cleared 510(K)
- K896522DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY1Cleared 510(K)
- K895943NORMAL AND ABNORMAL CONTROL SERA1Cleared 510(K)
- K894852SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS1Cleared 510(K)
- K894078LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II1Cleared 510(K)
- K894252LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM1Cleared 510(K)
- K893580DADE LIPID-TROL1Cleared 510(K)
- K893141DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET1Cleared 510(K)
- K893142DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET1Cleared 510(K)
- K891680LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II1Cleared 510(K)
- K891929MONI-TROL(R)1Cleared 510(K)
- K890708AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)1Cleared 510(K)
- K890470RIATRAC PLUS1Cleared 510(K)
- K890414RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)1Cleared 510(K)
- K890576KENLOR HUMAN SPINAL FLUID CONTROL LIQUID1Cleared 510(K)
- K890442SHAPE-ACTIO URINALYSIS CONTROLS1Cleared 510(K)
- K884977GAS TRAK PLUS1Cleared 510(K)
- K883942HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL1Cleared 510(K)
- K882486LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II1Cleared 510(K)
- K883861DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST1Cleared 510(K)
- K882736AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA1Cleared 510(K)
- K883147TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1Cleared 510(K)
- K882728AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.41901Cleared 510(K)
- K883124AMERLITE FREE THYROID CONTROL SERA LAN.40021Cleared 510(K)
- K883247LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL1Cleared 510(K)
- K883012A.QC CHEMISTRY CONTROL LEVEL 21Cleared 510(K)
- K882727AMERLITE TOTAL THYROID CONTROL SERA LAN.40011Cleared 510(K)
- K882542LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II1Cleared 510(K)
- K881503MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL1Cleared 510(K)
- K881438UREA/GLUCOSE/CREATININE SERUM RANGE LINEARITY STAN1Cleared 510(K)
- K881437CHLORIDE/TOTAL CO2 SERUM RANGE LINEARITY STANDARDS1Cleared 510(K)
- K881113CLP LIPOPROTEIN ELECTROPHORESIS CONTROL1Cleared 510(K)
- K881436SODIUM/POTASSIUM SERUM RANGE LINEARITY STANDARDS1Cleared 510(K)
- K881229AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 166931Cleared 510(K)
- K880447MULTI-FUNCTION BLOOD GAS CONTROL1Cleared 510(K)
- K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II1Cleared 510(K)
- K880494LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)1Cleared 510(K)
- K880175DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL1Cleared 510(K)
- K874731LYPHOCHEK WHOLE BLOOD CONTROL1Cleared 510(K)
- K874280LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II1Cleared 510(K)
- K874809REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM1Cleared 510(K)
- K874810REFERENCE ASSAYED CHEMISTRY CONTROL SERUM1Cleared 510(K)
- K874772DC-TROL LEVEL 1 OR 21Cleared 510(K)
- K874459LIQUI-SERA SPINAL FLUID CONTROL1Cleared 510(K)
- K874230PRECINORM L1Cleared 510(K)
- K873611A-QC CLINICAL CHEMISTRY CONTROL1Cleared 510(K)
- K872785BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM1Cleared 510(K)
- K872777BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL1Cleared 510(K)
- K872376LIPID CONTROL SERUM1Cleared 510(K)
- K871977DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR1Cleared 510(K)
- K872304UNASSAYED CONTROL SERUM, NORMAL (BOVINE)1Cleared 510(K)
- K872303UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)1Cleared 510(K)
- K872227LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II1Cleared 510(K)
- K871342QM2/QM300 CONTROL A PACK1Cleared 510(K)
- K871537CANTROL HDL CHOLESTROL CONTROLS LEVELS I AND II1Cleared 510(K)
- K871058SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN)1Cleared 510(K)
- K870684LIQUID CHEMISTRY CONTROL, LEVEL I1Cleared 510(K)
- K870683LIQUID CHEMISTRY CONTROL, LEVEL II1Cleared 510(K)
- K870252DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET1Cleared 510(K)
- K862565CHEMTROL(TM)1Cleared 510(K)
- K861202TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS1Cleared 510(K)
- K863849LIQUI-SERA COMBO LIGAND/TDM CONTROLS1Cleared 510(K)
- K863751MULTI-ANALYTE LIN-TROL1Cleared 510(K)
- K863648SERACON CT REFERENCE1Cleared 510(K)
- K863745ABNORMAL SPINAL FLUID CONTROL1Cleared 510(K)
- K861420QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL1Cleared 510(K)
- K862963THERAPEUTIC DRUG MONITORING CONTROL SET1Cleared 510(K)
- K862586CHEMVARION(TM)1Cleared 510(K)
- K862587CHEMTROL(TM)1Cleared 510(K)
- K862420UTAK-STABBS TOXICOLOGY CONTROL1Cleared 510(K)
- K862278GAS-TRAK1Cleared 510(K)
- K862185LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL1Cleared 510(K)
- K860999GILFORD UNIQUAL ABNORMAL CONTROL SERUM/ASSAYED1Cleared 510(K)
- K862179SOMAS LIQUID URINE CONTROL1Cleared 510(K)
- K861901MULTI-4 CO-OXIMETER CONTROL1Cleared 510(K)
- K860906STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III1Cleared 510(K)
- K861603IRON PROCEDURE1Cleared 510(K)
- K861567CONTROL SERA LEVEL VALUES (MG/DL)1Cleared 510(K)
- K861185THERACHEM-PLUS, TRI-LEVEL TDC (TM)1Cleared 510(K)
- K860942QUANTIMETRIX HUMAN BILIRUBIN CONTROL I & II LIQUID1Cleared 510(K)
- K861448QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID1Cleared 510(K)
- K861068GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED1Cleared 510(K)
- K861000GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED1Cleared 510(K)
- K860998GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED1Cleared 510(K)
- K860970PRECINORM IM AND PRECIPATH IM1Cleared 510(K)
- K860355BOVINE CHEMISTRY CONTROL I.X AND II.X1Cleared 510(K)
- K855036CHEMISTRY CONTROL N & A1Cleared 510(K)
- K855035CALIBRATION REFERENCE I & II1Cleared 510(K)
- K854931CANTROL ELECTROPHORESIS CONTROL1Cleared 510(K)
- K854789RANGE-CHEK1Cleared 510(K)
- K854967CRITIC - SF, ASSAYED1Cleared 510(K)
- K853943CRITIC C LEVEL I & II1Cleared 510(K)
- K854119ACCURACY1Cleared 510(K)
- K853931QUANTIMETRIX HUMAN SERUM CHEMISTRY CONTROL1Cleared 510(K)
- K853906LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)1Cleared 510(K)
- K852753DC LIQUITROL LEVEL 1 & 21Cleared 510(K)
- K852418QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)1Cleared 510(K)
- K851820SPINAL FLUID CONTROL1Cleared 510(K)
- K852594DC-LIP, CATALOGUE NUMBER SE-0201Cleared 510(K)
- K851942COULTER DOUBLE CHECK, UNASSAYED SERUM CHEMISTRY1Cleared 510(K)
- K850574DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO1Cleared 510(K)
- K850575DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H1Cleared 510(K)
- K850017PRECINORM H & PRECIPATH H1Cleared 510(K)
- K844848IMA-TROL IMMUNOASSAY CONTROL1Cleared 510(K)
- K844413ULTROSER G1Cleared 510(K)
- K850202GELMAN TRIPHOR CONTROL1Cleared 510(K)
- K844996PARAGON TRICHECK ELECTROPHORESIS CONTROL1Cleared 510(K)
- K844760UROL-QUAL1Cleared 510(K)
- K844125LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN1Cleared 510(K)
- K844018GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 31Cleared 510(K)
- K843986STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 31Cleared 510(K)
- K843611QUALIFY I & II AMER. MONITOR 2009 & 20101Cleared 510(K)
- K842970ALLERGENTICS TOTAL IGE/THEOPHYLLINE1Cleared 510(K)
- K841884KODAK EKTACHEM CONTROL1Cleared 510(K)
- K841452NOVA STAT CONTROL LEVELS 1/2/31Cleared 510(K)
- K840458BIOTIS ABNORMAL CLINICAL CHEM SERUM-1Cleared 510(K)
- K840457NORMAL CLINICAL CHEM. CONTROL SERUM-1Cleared 510(K)
- K834064ORTHO BI-LEVEL RECEPTOR CONTROL1Cleared 510(K)
- K833009OMNI-FAL I & II1Cleared 510(K)
- K833639TITANGEL HIGH RESOLUTION CONTROL1Cleared 510(K)
- K833423VENTREZYME EIA CONTROLS-IMMUNOASSAY1Cleared 510(K)
- K833192NORMAL URINE CONTROL1Cleared 510(K)
- K833191ABNORMAL URINE CONTROL1Cleared 510(K)
- K831263ELECTROPHORESIS CONTROLS-3 IN 11Cleared 510(K)
- K830179BIOCELL SPINAL FLUID CONTROL1Cleared 510(K)
- K823352IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS1Cleared 510(K)
- K823929MULTIANALYTE CONTROLS-ALL KINDS1Cleared 510(K)
- K823490ORTHO BI-LEVEL ASSAYED LIPID PROFILE1Cleared 510(K)
- K822850MONI-TRO ES CHEMISTRY CONTROL LEVEL IX1Cleared 510(K)
- K821982TITAN GEL SERUM CONTROL1Cleared 510(K)
- K821026BI-LEVEL ASSAYED TUMOR MARKER & ANTIN1Cleared 510(K)
- K822133IGE/THE OPHYLLINE CONTROL SERUM I,II,III1Cleared 510(K)
- K821559LEVEL I LIPID CONTROL1Cleared 510(K)
- K821560LEVEL II LIPID CONTROL1Cleared 510(K)
- K821557LEVEL I CONTROL SERUM1Cleared 510(K)
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- K802108KEMTROL SERUM CONTROL-NORMAL1Cleared 510(K)
- K801539ASSURE LEVEL II PROD. #301721Cleared 510(K)
- K801538ASSURE LEVEL I PROD. #301711Cleared 510(K)
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- K800559SERTROL PRODUCT # ACS ST 1011Cleared 510(K)
- K800370CK/LD ISOENZYME CONTROL PROD. #ACS CT1011Cleared 510(K)
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- K792024LIPOTROL1Cleared 510(K)
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- K791958SERACON - EL DO271Cleared 510(K)
- K791825LY-PRO-TROL #ACS-LP1011Cleared 510(K)
- K791696CONTRO II1Cleared 510(K)
- K791695CONTRO I1Cleared 510(K)
- K791654NORMAL CONTROL1Cleared 510(K)
- K791313ARS, CHEMISTRY1Cleared 510(K)
- K791119MACOMB NORMAL CONTROL SERUM1Cleared 510(K)
- K790840THYROID CONTROL SERA CODE QAS.1011Cleared 510(K)
- K790371MACOMB LIPID CONTROL1Cleared 510(K)
- K790264DATA-TOPE TRI-RAC RADIOASSAY CONTROL1Cleared 510(K)
- K790330CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN1Cleared 510(K)
- K782038SERACON-C1Cleared 510(K)
- K781893CONTROL, PROTEIN ELECTROPHORESIS1Cleared 510(K)
- K781593RIA CONTROLS1Cleared 510(K)
- K780552COMP. CLIN. CHEM. CONTROL SERUM-DECISION1Cleared 510(K)
- K780351NORMAL UNASSAYED CONTROL SERA1Cleared 510(K)
- K780096LDH ISOENZYME CONTROL SERUM1Cleared 510(K)
- K771437SERONORM LIPID1Cleared 510(K)
- K770380CHEMISTRY CONTROL-LOW & HIGH TQC TM1Cleared 510(K)
- K770310CHEMISTRY CONTROL, NORMAL1Cleared 510(K)
- K770312CHEMISTRY CONTROL, ABNORMAL1Cleared 510(K)
- K760818TRIS BICARBONATE DILUENT1Cleared 510(K)
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- JNFIon-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen1Product Code
- JNGRadioimmunoassay, Pregnenolone1Product Code
- JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate Kinase1Product Code
- JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol Dehydrogenase1Product Code
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin1Product Code
- JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin1Product Code
- JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)1Product Code
- JNQQualitative Chemical Reactions, Urinary Calculi (Stone)1Product Code
- JNSStannous Chloride - Hydrazine, Phospholipids1Product Code
- JNTChromatographic, Phospholipids1Product Code
- JNXMembrane Osmometry, Plasma Oncometry1Product Code
- JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate Isomerase1Product Code
- JNZFluorometric, Uroporphyrin1Product Code
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- JOBHexane Extraction, Fluorescence, Vitamin E1Product Code
- JOCColorimetric, Xylose1Product Code
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQAElectrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes1Product Code
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
- JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity1Product Code
- JQFBathophenanthroline, Iron Binding Capacity1Product Code
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- JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JQIRotating Disc, Plasma Viscometry1Product Code
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- JQNColorimetric, Mucopolysaccharides1Product Code
- KHMNephelometric, Amylase2Product Code
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- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
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- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
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- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K040352
- 510(k) Type
- Traditional
- Applicant
- Bioresource Technology, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/2/2004
- Days to Decision
- 50 days
- Submission Type
- Statement