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
- K171168VITROS Immunodiagnostic Products Insulin Calibrators2Cleared 510(K)
- K170938CalSet IGF-12Cleared 510(K)
- K170160Abbott ARCHITECT Free T32Cleared 510(K)
- K163534Lumipulse G FSH-N Calibrators2Cleared 510(K)
- K163546Lumipulse G Progesterone-N Calibrators2Cleared 510(K)
- K163544Lumipulse G Prolactin2Cleared 510(K)
- K163521Lumipulse G LH Calibrators2Cleared 510(K)
- K163078DC-UIBC-CAL2Cleared 510(K)
- K163053Lumipulse G E2-III Calibrators2Cleared 510(K)
- K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2Cleared 510(K)
- K160113ST AIA-PACK hsE2 Calibrator Set2Cleared 510(K)
- K153417ST AIA-PACK PROG III Calibrator Set2Cleared 510(K)
- K152526Elecsys Progesterone III CalSet2Cleared 510(K)
- K151566Abbott ARCHITECT Total T4 Calibrators2Cleared 510(K)
- K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator2Cleared 510(K)
- K143342Elecsys T-Uptake Calset2Cleared 510(K)
- K143144ST AIA-PACK PROG II Calibrator Set2Cleared 510(K)
- K142181RANDOX ALDOLASE CALIBRATION SERUM2Cleared 510(K)
- K142021Elecsys Estradiol III CalSet2Cleared 510(K)
- K133751DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS2Cleared 510(K)
- K141728ACE CALIBRATOR2Cleared 510(K)
- K141374BICARBONATE CALIBRATOR2Cleared 510(K)
- K140112CA 125 II CALSET II2Cleared 510(K)
- K140648ST AIA-PACK C-PEPTIDE II CALIBRATOR SET2Cleared 510(K)
- K130603PATHFAST CTNL CALIBRATORS2Cleared 510(K)
- K132400LP(A) CALIBRATORS, AND LP(A) CONTROLS2Cleared 510(K)
- K130628PATHFAST CK-MB-II CALIBRATORS2Cleared 510(K)
- K131556DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET2Cleared 510(K)
- K130698DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)2Cleared 510(K)
- K122177ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL2Cleared 510(K)
- K121027DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH2Cleared 510(K)
- K120591DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-22Cleared 510(K)
- K113373DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL2Cleared 510(K)
- K111952ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A980332Cleared 510(K)
- K111762ST AIA-PACK DHEA-S CALIBRATOR SET2Cleared 510(K)
- K111023ABBOTT ARCHITECT LH CALIBRATORS2Cleared 510(K)
- K103548ADVIA CENTAUR CALIBARATOR 80 MODEL 104924912Cleared 510(K)
- K110169DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H2Cleared 510(K)
- K103836ENZYME II CALIBRATOR2Cleared 510(K)
- K103221ELECYS HGH CALSET, ELECSYS HGH CALCHECK 52Cleared 510(K)
- K103360DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL2Cleared 510(K)
- K102638DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS2Cleared 510(K)
- K092937STA-HYBRID HEP CALIBRATOR2Cleared 510(K)
- K093357DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D2Cleared 510(K)
- K100293ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/103798102Cleared 510(K)
- K092570ABX PENTRA TPU CAL, MODEL A11A018982Cleared 510(K)
- K083462DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC3502Cleared 510(K)
- K082680LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC6232Cleared 510(K)
- K081789DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR2Cleared 510(K)
- K082141ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-102Cleared 510(K)
- K081319DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC562Cleared 510(K)
- K081683LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC6212Cleared 510(K)
- K080166ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 335452Cleared 510(K)
- K072717DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC2102Cleared 510(K)
- K071039MISSION OLYMPUS AU ISE CALIBRATORS2Cleared 510(K)
- K070552DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)2Cleared 510(K)
- K062521OXALATE URINE CONTROLS (NORMAL AND ELEVATED)2Cleared 510(K)
- K070144INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS2Cleared 510(K)
- K060854ABX PENTRA 400: LIPOPROTEINS2Cleared 510(K)
- K062152CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC272Cleared 510(K)
- K061885DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC2502Cleared 510(K)
- K061818DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)2Cleared 510(K)
- K061751DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC2602Cleared 510(K)
- K061702DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)2Cleared 510(K)
- K061139BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS2Cleared 510(K)
- K061282ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 335852Cleared 510(K)
- K060140CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-2502Cleared 510(K)
- K060754ELECSYS TSH CALSET W/MODELS 047385512Cleared 510(K)
- K060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-102Cleared 510(K)
- K060322CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED2Cleared 510(K)
- K053291FERRITIN CALIBRATOR SET, CATALOG NO. 82032Cleared 510(K)
- K060371THE EMIT 2000 TACROLIMUS CALIBRATORS2Cleared 510(K)
- K053576DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR2Cleared 510(K)
- K053330ARCHITECT B12 CALIBRATORS2Cleared 510(K)
- K052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET2Cleared 510(K)
- K052982ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET2Cleared 510(K)
- K052193ISE COMPENSATOR2Cleared 510(K)
- K052002IRON STANDARD2Cleared 510(K)
- K051012PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.2Cleared 510(K)
- K050231ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET2Cleared 510(K)
- K043378DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT2Cleared 510(K)
- K042838VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II2Cleared 510(K)
- K042406OLYMPUS LACTATE, OSR61932Cleared 510(K)
- K043095ROCHE DIAGNOSTICS ELECSYS AFP CALSET II2Cleared 510(K)
- K042521VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS2Cleared 510(K)
- K042307ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)2Cleared 510(K)
- K042651FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS2Cleared 510(K)
- K042490ELECSYS FOLATE II CALSET II2Cleared 510(K)
- K033860AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR2Cleared 510(K)
- K040692OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC00232Cleared 510(K)
- K040226WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET2Cleared 510(K)
- K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC00242Cleared 510(K)
- K033060CALIBRATING MATERIAL, CALIBRATING STANDARDS2Cleared 510(K)
- K033786LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA2Cleared 510(K)
- K033643CO2 CALIBRATOR/DILUENT2Cleared 510(K)
- K032458ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT2Cleared 510(K)
- K032285OLYMPUS PREALBUMIN CALIBRATOR, ODR30292Cleared 510(K)
- K031924VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 12Cleared 510(K)
- K031159CALIBRATING MATERIAL, CALIBRATING STANDARDS2Cleared 510(K)
- K031299ELECSYS LH CALSET II2Cleared 510(K)
- K030772RDI EXTENDED RANGE CRP CALIBRATOR SET2Cleared 510(K)
- K022533FASTPACK TESTOSTERONE CALIBRATOR2Cleared 510(K)
- K022027CALIBRATING MATERIAL, BUFFERS, STANDARD2Cleared 510(K)
- K021607RDI HS CRP CALIBRATOR SET2Cleared 510(K)
- K021532ADVIA CENTAUR AND ACS:180 C-PEPTIDE CALIBRATOR2Cleared 510(K)
- K021535ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR2Cleared 510(K)
- K020980DIMENSION TPSA CALIBRATOR, MODEL #RC4592Cleared 510(K)
- K020723DIMENSION ALDL CALIBRATOR, MODEL DC1312Cleared 510(K)
- K020894CALIBRATING MATERIAL, CAL-PAK, BUFFERS2Cleared 510(K)
- K020454CHEMISTRY CALIBRATOR2Cleared 510(K)
- K020596CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS2Cleared 510(K)
- K013850STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE2Cleared 510(K)
- K012900ACCESS UNCONJUGATED ESTRIOL CALIBRATORS2Cleared 510(K)
- K012367VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D2Cleared 510(K)
- K012233STRATUS CS TROPONIN I CALIBRATOR2Cleared 510(K)
- K012399MODIFICATION TO ELECSYS FSH II CALSET2Cleared 510(K)
- K010332WAKO IMMUNOASSAY CALIBRATOR SET2Cleared 510(K)
- K010334WAKO LIPID CALIBRATOR2Cleared 510(K)
- K011126RAICHEM CREATININE URINE STANDARD2Cleared 510(K)
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- K771797ACA TRIGLYCERIDE CALIBRATOR2Cleared 510(K)
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- K771803ACA PHOSPHORUS CALIBRATOR2Cleared 510(K)
- K771804ACA AMMONIA CALIBRATOR2Cleared 510(K)
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- K771215CENTRIFICHEM TRIGLYCERIDE CALI. STD.2Cleared 510(K)
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- K770277CHOLESTEROL STANDARDS2Cleared 510(K)
- K770126CENTRIFICHEM CHOLES. CALIB. STD. SET2Cleared 510(K)
- K770127CENTRIFICHEM 200MG/DL CHOL. CAL. STD.2Cleared 510(K)
- K761197CHOLESTEROL CALIBRATOR2Cleared 510(K)
- K760349BILIRUBIN REF., SIGMA STOCK NO. 605-102Cleared 510(K)
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- JIXCalibrator, Multi-Analyte Mixture2Product Code
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- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1Product Code
- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
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- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
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- JLHTitrimetric, Fatty Acids1Product Code
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- JLQSpectrophotometric Method, Pregnanetriol1Product Code
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- JMERadioimmunoassay, Glucagon1Product Code
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- JMJMicrobiological, Histidine1Product Code
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- JMMColumn Chromatography & Color Development, Hydroxyproline1Product Code
- JMNExtraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline1Product Code
- JMOFerrozine (Colorimetric) Iron Binding Capacity1Product Code
- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)1Product Code
- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
- JMSAcid, Oxalacetic And Nadh Oxidation (U.V.), Malic Dehydrogenase1Product Code
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)1Product Code
- JMW2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JMXNinhydrin, Nitrogen (Amino-Nitrogen)1Product Code
- JMYCitrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase1Product Code
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality1Product Code
- JNAVapor Pressure, Osmolality Of Serum & Urine1Product Code
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine2Product Code
- JNCColumn Or Paper Chromatography Plus Ninhydrin, Phenylalanine2Product Code
- JNDNadp Reduction, 6-Phosphogluconate Dehydrogenase1Product Code
- JNEGlucose-6-Phosphate (Colorimetric), Phosphohexose Isomerase1Product Code
- 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
- JOAAcid, Trifluoroacetic, Vitamin A, Hexane Extraction1Product Code
- JOBHexane Extraction, Fluorescence, Vitamin E1Product Code
- JOCColorimetric, Xylose1Product Code
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- 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
- JQGRadiometric, Fe59, Iron Binding Capacity1Product Code
- JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)1Product Code
- JQIRotating Disc, Plasma Viscometry1Product Code
- JQJDensitometeric, Protein Fractionation1Product Code
- JQKImmunodiffusion, Protein Fractionation1Product Code
- JQLSpectrophotometric, Uroporphyrin1Product Code
- JQMP-Bromoaniline, Xylose1Product Code
- JQNColorimetric, Mucopolysaccharides1Product Code
- KHMNephelometric, Amylase2Product Code
- KHPAcid, Lactic, Enzymatic Method1Product Code
- KHQRadioassay, Triiodothyronine Uptake2Product Code
- KHSEnzymatic, Carbon-Dioxide2Product Code
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine2Product Code
- KLJNad Reduction (U.V.), Phosphohexose Isomerase1Product Code
- KMSPhenolphthalein Colorimetry, Carbon-Dioxide2Product Code
- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
- KQNRadioassay, Angiotensin Converting Enzyme2Product Code
- KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase2Product Code
- KWWRadioimmunoassay, Cholyglycine, Bile Acids2Product Code
- KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids2Product Code
- LBRLdl & Vldl Precipitation, Hdl1Product Code
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl1Product Code
- LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical1Product Code
- LCXKit, Test, Pregnancy, Hcg, Over The Counter2Product Code
- LFPConductivity Rate, Urea Nitrogen2Product Code
- LFQAcid, Uric, Acid Reduction Of Ferric Ion1Product Code
- LFRGlucose Dehydrogenase, Glucose2Product Code
- LFSRadioreceptor Assay, Human Chorionic Gonadotropin2Product Code
- LIGRadioassay, Intrinsic Factor Blocking Antibody2Product Code
- LPSUrinary Homocystine (Nonquantitative) Test System2Product Code
- LPTSystem, Test, Urinary Methylmalonic Acid2Product Code
- LPWSystem, Test, Oxalate1Product Code
- MMIImmunoassay Method, Troponin Subunit2Product Code
- MPGUrinary Carbohydrate Analysis Kit1Product Code
- MQMBilirubin (Total And Unbound) In The Neonate Test System1Product Code
- MRGSystem, Test, Vitamin D2Product Code
- MRRSystem, Test, Low Density, Lipoprotein1Product Code
- MRVDrink, Glucose Tolerance2Product Code
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- MSMSystem, Test, Lipoprotein(A)1Product Code
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- MZUSystem, Test, Sodium, Enzymatic Method2Product Code
- MZVTest, System, Potassium, Enzymatic Method2Product Code
- NAKSystem, Test, Biotinidase2Product Code
- NALTest, Immunoassay, Biosensor, Hcg2Product Code
- NAOTest, Carbohydrate Deficient Transferrin1Product Code
- NAQLipoprotein, High Density, Hdl, Over The Counter1Product Code
- NBCTest, Natriuretic Peptide2Product Code
- NBWSystem, Test, Blood Glucose, Over The Counter2Product Code
- NDREnzyme Immunoassay, Inhibin-A1Product Code
- NDYTest, Cystatin C2Product Code
- NEOSystem, Test, Osteocalcin2Product Code
- NHGEnzyme Immunoassay, Cortisol, Salivary2Product Code
- NJVTest, Albumin Cobalt Binding2Product Code
- NQLSystem, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry2Product Code
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- NRHSystem, Breath Measurement1Product Code
- OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-11Product Code
- OHQMulti-Analyte Controls Unassayed1Product Code
- OLDInternal Polymerase Chain Reaction Control, Not Assay Specific1Product Code
- ONDOsmolality Of Tears1Product Code
- OSXGalectin-3 In Vitro Diagnostic Assay2Product Code
- OYGSt2 Assay2Product Code
- OYJDna Specimen Collection, Saliva2Product Code
- PDJHemoglobin A1c Test System2Product Code
- PDSAmniotic Fluid Protein Immunoassay1Product Code
- PFQMmp-9 Test System1Product Code
- PIGAcute Kidney Injury Test System2Product Code
- PJCNewborn Screening Specimen Collection Paper2Product Code
- PJDOral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device2Product Code
- PJEBlood/Plasma Collection Device For Dna Testing2Product Code
- PJTContinuous Glucose Monitor Secondary Display2Product Code
- PKUInsulin Pump Secondary Display2Product Code
- PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)2Product Code
- PQTAlpha-L-Iduronidase (Idua) Newborn Screening Test System2Product Code
- PQUAlpha-D-Glucosidase (Gaa) Newborn Screening Test System2Product Code
- PQVß-Glucocerebrosidase (Gba) Newborn Screening Test System2Product Code
- PQWAlpha-D-Galactosidase A (Gla) Newborn Screening Test System2Product Code
- PRJCapillary Blood Collection Device For Alternative Site Collection2Product Code
- PSL25-Oh-Vitamin D Mass Spectrometry Test System2Product Code
- PTCUric Acid Test System For At Home Prescription Use1Product Code
- PYPLow-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test1Product Code
- PYVHospital Continuous Glucose Monitoring System2Product Code
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing2Product Code
- QBJIntegrated Continuous Glucose Monitoring System, Factory Calibrated2Product Code
- QCCInsulin Pump Therapy Adjustment Calculator For Healthcare Professionals2Product Code
- QCLAcid-Sphingomyelinase (Asm) Newborn Screening Test System2Product Code
- QCMß-Galactocerebrosidase (Galc) Newborn Screening Test System2Product Code
- QDHMenopause Test System2Product Code
- QDKIntegrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management2Product Code
- QDLIntegrated Continuous Glucose Monitoring System For Professional Retrospective Use2Product Code
- QEIBreast Milk Macronutrients Test System2Product Code
- QIIIntegrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use2Product Code
- QJEMuscular Dystrophy Newborn Screening Test2Product Code
- QJIInteroperable Automated Glycemic Controller2Product Code
- QJSInteroperable Automated Glycemic Controller, Insulin Suspend2Product Code
- QLGIntegrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems2Product Code
- QMABlood Collection Device For Cell-Free Nucleic Acid2Product Code
- QQBPrognostic Test For Assessment Of Liver Related Disease Progression2Product Code
- OJQCardiac Allograft Gene Expression Profiling Test System2Product Code
- QRXContinuous Glucose Monitor Informed Insulin Dose Calculator2Product Code
- QZGMenstrual Blood Collection Device2Product Code
- SAFIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter2Product Code
- SBHIntegrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter2Product Code
- SFOElectrode Measurement, Drain Effluent Ph2Product Code
- 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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ST AIA-PACK hsE2 Calibrator Set
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160113
- 510(k) Type
- Traditional
- Applicant
- TOSOH BIOSCIENCE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/17/2016
- Days to Decision
- 29 days
- Submission Type
- Summary