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
- JKATubes, Vials, Systems, Serum Separators, Blood Collection2Product Code
- JKBRadioimmunoassay, Compound S (11-Deoxycortisol)1Product Code
- JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)1Product Code
- JKDRadioimmunoassay, C-Peptides Of Proinsulin1Product Code
- JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric Dehydroge1Product Code
- JKGL-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase1Product Code
- JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric Dehydrogen1Product Code
- JKJFluorometric Measurement, Porphyrins1Product Code
- JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry1Product Code
- JKPChromium-51, Blood Volume1Product Code
- JKRRadioimmunoassay, Calcitonin2Product Code
- JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKYOxalydihydrazide (Spectroscopic), Copper1Product Code
- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
- JLAConversion To Creatinine, Creatine1Product Code
- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
- JLCNitroprusside Reaction (Qualitative, Urine), Cystine1Product Code
- JLDChromatographic, Cystine1Product Code
- JLERadioimmunoassay, Desoxycorticosterone1Product Code
- JLFRadioimmunoassay, Etiocholanolone1Product Code
- JLGConversion To Ferric Hydroxymates (Colorimetric), Fatty Acids1Product Code
- JLHTitrimetric, Fatty Acids1Product Code
- JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic Acid1Product Code
- JLJUridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate2Product Code
- JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric Acidity1Product Code
- JLLTubeless Analysis, Gastric Acidity1Product Code
- JLNChromatographic, Glutathione1Product Code
- JLOEnzymatic (Glutathione Reductase), Glutathione1Product Code
- JLPSpectrophotometric Method, Pregnanediol1Product Code
- JLQSpectrophotometric Method, Pregnanetriol1Product Code
- JLRGas Chromatography, Pregnanetriol1Product Code
- JLSRadioimmunoassay, Progesterone1Product Code
- JLTAcid, Pyruvic, Enzymatic (U.V.)1Product Code
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone2Product Code
- K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)2Cleared 510(K)
- K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B02Cleared 510(K)
- K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)2Cleared 510(K)
- K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)2Cleared 510(K)
- K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer2Cleared 510(K)
- K190773Elecsys TSH2Cleared 510(K)
- K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer2Cleared 510(K)
- K171103Lumipulse G TSH-III Immunoreaction Cartridges2Cleared 510(K)
- K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer2Cleared 510(K)
- K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzer2Cleared 510(K)
- K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control2Cleared 510(K)
- K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems2Cleared 510(K)
- K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T42Cleared 510(K)
- K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System2Cleared 510(K)
- K150403ADVIA Centaur TSH3-Ultra2Cleared 510(K)
- K141999ADVIA CENTAUR TSH2Cleared 510(K)
- K131928FREND TSH (REAGENT CARTRIDGE)2Cleared 510(K)
- K130469LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 32Cleared 510(K)
- K110761MICT TSH2Cleared 510(K)
- K101390FASTPACK TSH IMMUNOASSAY2Cleared 510(K)
- K090846GSP INSTRUMENT AND GSP NEONATAL HTSH KIT2Cleared 510(K)
- K083844ADVIA CENTAUR TSH3-ULTRA METHOD2Cleared 510(K)
- K083173VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM2Cleared 510(K)
- K081543VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM2Cleared 510(K)
- K081074DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD6912Cleared 510(K)
- K072458GBI TSH NEONATAL SCREENING KIT2Cleared 510(K)
- K063437ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-3002Cleared 510(K)
- K062581OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM2Cleared 510(K)
- K060090DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE2Cleared 510(K)
- K052301FASTPACK TSH IMMUNOASSAY2Cleared 510(K)
- K042281MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY2Cleared 510(K)
- K041014TSH-CTK-3 IRMA2Cleared 510(K)
- K030912THYRO TEST2Cleared 510(K)
- K023093ACCESS HYPERSENSITIVE HTSH ASSAY2Cleared 510(K)
- K013420CHEMWELL, ALSO KNOWN AS PROJECT 29002Cleared 510(K)
- K011527PRAXSYS RELIA TSH TEST2Cleared 510(K)
- K011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)2Cleared 510(K)
- K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)2Cleared 510(K)
- K001455ACCUWELL TSH, MODEL KAW-TSH-9602Cleared 510(K)
- K001606REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)2Cleared 510(K)
- K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-10012Cleared 510(K)
- K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-10032Cleared 510(K)
- K990658THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY2Cleared 510(K)
- K983442ABBOTT ARCHITECT TSH2Cleared 510(K)
- K9813123RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM2Cleared 510(K)
- K981060ABBOTT AXSYM 3RD GENERATION TSH ASSAY2Cleared 510(K)
- K980574AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL02Cleared 510(K)
- K973276AUTODELFIA NEONATAL HTSH L KIT (B077-112)2Cleared 510(K)
- K972586AIA-PACK TSH 3RD-GEN ASSAY2Cleared 510(K)
- K971780THYROTROPIN(TSH) ELISA2Cleared 510(K)
- K970393THYROID STIMULATING HORMONE METHOD2Cleared 510(K)
- K964558VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)2Cleared 510(K)
- K961566BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS2Cleared 510(K)
- K962464SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)2Cleared 510(K)
- K962216TSH (MICROWELL) ELISA2Cleared 510(K)
- K961629THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST2Cleared 510(K)
- K961491ELECSYS TSH ASSAY2Cleared 510(K)
- K961650NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT2Cleared 510(K)
- K960195THYROCHEK ONE-STEP RAPID TSH ASSAY2Cleared 510(K)
- K954825ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER2Cleared 510(K)
- K952211AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q)2Cleared 510(K)
- K952148AXSYM ULTRASENSITIVE HTSH II2Cleared 510(K)
- K951796CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY2Cleared 510(K)
- K950921CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY2Cleared 510(K)
- K943195COAT-A-COUNT NEONATAL TSH IRMA2Cleared 510(K)
- K942658NEOSCREEN ELISA TSH2Cleared 510(K)
- K942661AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT2Cleared 510(K)
- K940006IMMULITE THIRD GENERATION (MODIFICATION)2Cleared 510(K)
- K935399RADIAS NEONATAL TSH ENZYME IMMUNOASSAY2Cleared 510(K)
- K933212IMMULITE RAPID TSH2Cleared 510(K)
- K941146DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM2Cleared 510(K)
- K935049ELEGANCE NEONATAL TSH ELISA2Cleared 510(K)
- K942566IMX ULTRASENSISTIVE HTSH II2Cleared 510(K)
- K934410AXSYM ULTRASENSITIVE HTSH2Cleared 510(K)
- K935119RADIAS 3RD GENERATION TSH IMMUNOASSAY2Cleared 510(K)
- K930776COBAS CORE TSH EIA2Cleared 510(K)
- K930006AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT2Cleared 510(K)
- K930050SIA THYROID STIMULATING HORMONE ELISA KIT2Cleared 510(K)
- K931061RADIAS TSH ENZYME IMMUNOASSAY2Cleared 510(K)
- K923532NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY2Cleared 510(K)
- K925637ACCESS HTSH ASSAY2Cleared 510(K)
- K925132BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE2Cleared 510(K)
- K923401DELFIA HTSH ULTRA KIT2Cleared 510(K)
- K922701DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD2Cleared 510(K)
- K922138VISTA ULTRASENSITIVE HTSH ASSAY2Cleared 510(K)
- K922736KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA2Cleared 510(K)
- K921958ELISA TUBE TSH TEST2Cleared 510(K)
- K921700TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF40932Cleared 510(K)
- K921816VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY2Cleared 510(K)
- K920856VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS2Cleared 510(K)
- K920442IMMUCHEM TSH-MW ELISA2Cleared 510(K)
- K915195ENZYMUN-TEST TSH2Cleared 510(K)
- K914756ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT2Cleared 510(K)
- K913963IMMUCHEM NEONATAL TSH-MP ELISA2Cleared 510(K)
- K912852STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO2Cleared 510(K)
- K912583MAGIC LITE TSH (HS) IMMUNOASSAY2Cleared 510(K)
- K912324NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY2Cleared 510(K)
- K912241STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY2Cleared 510(K)
- K910837SRI TSH IMMUNENZYMETRIC ASSAY2Cleared 510(K)
- K910981CIBA CORNING ACS TSH IMMUNOASSAY2Cleared 510(K)
- K910411MICROZYME TSH ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K910256ECLIPSE ICA TSH2Cleared 510(K)
- K905710PHARMACIA DELFIA NEONATAL HTSH KIT2Cleared 510(K)
- K905769IMMULITE HS-TSH2Cleared 510(K)
- K905099ELEGANCE TSH ELISA2Cleared 510(K)
- K904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20082Cleared 510(K)
- K903725EZ-BEAD TSH ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K903391ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM2Cleared 510(K)
- K903311NOVAPATH TSH ENZYME IMMUNOASSAY2Cleared 510(K)
- K902753IMX ULTRASENTITIVE HTSH2Cleared 510(K)
- K902333OPUS TSH TEST SYSTEM2Cleared 510(K)
- K900277ENZYMUN TEST(R) TSH-S2Cleared 510(K)
- K897138AFFINITY(TM) HTSH(TM)2Cleared 510(K)
- K896867THYROID STIMULATING HORMONE-EIA-XT2Cleared 510(K)
- K900014MILENIA (TM) TSH2Cleared 510(K)
- K895396CYBERFLUOR FIAGEN TSH2Cleared 510(K)
- K890802COTUBE(TM) TSH IRMA2Cleared 510(K)
- K890579TSH MICROASSAY2Cleared 510(K)
- K885157VENTREX COATED TUBE HIGH SENSITIVITY TSH2Cleared 510(K)
- K883742MODIFIED TSH IRMA KIT2Cleared 510(K)
- K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL2Cleared 510(K)
- K881627DELFIA(TM) NEONATAL HTSH KIT2Cleared 510(K)
- K882907AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT2Cleared 510(K)
- K883342VENTREX COATED TUBE TSH2Cleared 510(K)
- K881381REAGENTS FOR TSH ASSAY2Cleared 510(K)
- K881443LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY2Cleared 510(K)
- K880086ABBOTT IMX HTSH2Cleared 510(K)
- K874622FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-3012Cleared 510(K)
- K874061TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-10932Cleared 510(K)
- K873303BINAX L.S. TSH IRMA TEST KIT2Cleared 510(K)
- K872897TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.2Cleared 510(K)
- K872305IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX2Cleared 510(K)
- K871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT2Cleared 510(K)
- K870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT2Cleared 510(K)
- K871644DELFIA (TM) HTSH KIT2Cleared 510(K)
- K870244IQ TSH IMMUNOASSAY2Cleared 510(K)
- K870245AUTOPAK TSH MONOCLONAL IRMA KIT2Cleared 510(K)
- K870320DACOMED PENILE PROSTHESIS SIZER2Cleared 510(K)
- K865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT2Cleared 510(K)
- K865081AFFINITY(TM) HTSH IMMUNIT(TM)2Cleared 510(K)
- K864839TSH MAB IRMA2Cleared 510(K)
- K864659BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH2Cleared 510(K)
- K864677TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP2Cleared 510(K)
- K864133DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT2Cleared 510(K)
- K864134DSL-4800 ACTIVE TM TSH EIA SYSTEM2Cleared 510(K)
- K864079UBI MAGIWEL(TM) TSH QUANTITATIVE2Cleared 510(K)
- K863859TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM2Cleared 510(K)
- K862407CIBA CORNING MAGIC LITE TSH IMMUNOASSAY2Cleared 510(K)
- K862428STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY2Cleared 510(K)
- K860813MICROMEDIC HTSH MONOCLONAL IRMA KIT2Cleared 510(K)
- K861918V-TREND EIA TSH2Cleared 510(K)
- K862249TSH IRMA KIT2Cleared 510(K)
- K861573TERUMO SENSIBEAD EIA TSH KIT2Cleared 510(K)
- K861920SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO.2Cleared 510(K)
- K860824TSHK-NN RIA KIT2Cleared 510(K)
- K860288ECHOCLONAL HTSH IRMA2Cleared 510(K)
- K860054TSH-IRMA COAT-A-COUNT KIT2Cleared 510(K)
- K854379MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT2Cleared 510(K)
- K854087NML TSH IRMA2Cleared 510(K)
- K853977BETA-TSH-IRMA2Cleared 510(K)
- K853717ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM2Cleared 510(K)
- K852438NML TSH IRMA2Cleared 510(K)
- K852224LEE-BEAD TSH(EIA)2Cleared 510(K)
- K851329MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA2Cleared 510(K)
- K851980ENDAB TSH2Cleared 510(K)
- K851120DELFIA HTSH KIT2Cleared 510(K)
- K851148TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE2Cleared 510(K)
- K844583TSH-STAT2Cleared 510(K)
- K850376TERUMO SENSIBEAD EIA TSH KIT2Cleared 510(K)
- K843540ABBOTT HTSH EIA DIAGNOSTIC KIT2Cleared 510(K)
- K843395ENCORE TSH REAGENT2Cleared 510(K)
- K843545TSH QUIK RIA KIT2Cleared 510(K)
- K843281ACCUSCREEN TSH2Cleared 510(K)
- K842593SUCROSEP THYROID STIMULATING HORMONE2Cleared 510(K)
- K842948AMERLEX-M TSH RIA2Cleared 510(K)
- K841606BLOOD SPOT NEONATAL TSH RADIOIMMUNO2Cleared 510(K)
- K840088BIODEX ACT-O-KIT TSH-RIA-2Cleared 510(K)
- K833193RADIOIMMUNOASSAY, THYROID STIMU. HORMONE2Cleared 510(K)
- K833713SERUM THYROTROPIN ASSAY KIT, TIPSEP-2Cleared 510(K)
- K832813TANDEM-E THYROID STIMULATING HORMONE KIT2Cleared 510(K)
- K832823ENZYMUNE-TEST TSH2Cleared 510(K)
- K831972EPSILON TSH TEST KIT2Cleared 510(K)
- K832499PHASE II TSH KIT2Cleared 510(K)
- K832462AUTOPAK NEONATAL TSH RIA KIT2Cleared 510(K)
- K832313MAGIC TSH 125I RADIOIMMUNOASSAY2Cleared 510(K)
- K830928VENTREX ENZYME TSH KIT2Cleared 510(K)
- K830036NEONATAL NTSH RADIOIMMUNOASSAY SYS2Cleared 510(K)
- K823688DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO2Cleared 510(K)
- K822935THYROID STIMULATING HORMONE2Cleared 510(K)
- K822827HISH EIA DIAGNOSTIC KIT2Cleared 510(K)
- K822705TAMDEM-R THYROID STIMULATING HORMONE KIT2Cleared 510(K)
- K822291QUANTIMUNE HTSH IRMA2Cleared 510(K)
- K821620(125I) HTSH RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K821174TSH-SQUIBB RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K820089TSH (RIA) KIT2Cleared 510(K)
- K813645MICROMEDIC HTSH RIA KIT2Cleared 510(K)
- K813525IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY2Cleared 510(K)
- K813392RADIOIMMUNOASSAY FOR HUMAN THYROID2Cleared 510(K)
- K812136AMERLEX TSH RIA KIT2Cleared 510(K)
- K811558TSH-P.E.G.2Cleared 510(K)
- K811431TECHNICON STAR SYSTEM2Cleared 510(K)
- K810948RADIOIMMUNOASSAY THYROID STIM. HORM. KIT2Cleared 510(K)
- K810213DAC-CEL TSH2Cleared 510(K)
- K802467TSH RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K801691TSH RIASSAY2Cleared 510(K)
- K801560VENTREX/SEP TSH TEST SET2Cleared 510(K)
- K800798HUMAN THYROID STIM. HORMONE/ARIA II2Cleared 510(K)
- K792562IMMUNOSTAT TSH TEST2Cleared 510(K)
- K792443TSH RADIOIMMUNOASSAY2Cleared 510(K)
- K792154THYROID STIMULATING HORMONE2Cleared 510(K)
- K791747HTSH NEONATE RIA DIAGNOSTIC KIT2Cleared 510(K)
- K791855CENTRIA TSH RIA2Cleared 510(K)
- K791301ORTHO TSH RIA KIT2Cleared 510(K)
- K791217TSH RIA KIT2Cleared 510(K)
- K791065IMMUNOSPOT TSH TEST2Cleared 510(K)
- K790260NTSH AUTOPAK TEST DELIVERY SYSTEM2Cleared 510(K)
- K781953RIA KIT, IMMO PHASE2Cleared 510(K)
- K781409IMMO PHASE, THYROID HORMONE2Cleared 510(K)
- K781296THYRO-SHURE2Cleared 510(K)
- K781170QUANTIMUNE HTSH IRMA HUMAN THYROID2Cleared 510(K)
- K781150RIA TSH IN HUMAN SERUM OR PLASMA2Cleared 510(K)
- K780726TSH RIA KIT2Cleared 510(K)
- K780428ROCHE TSH RIA2Cleared 510(K)
- K780059RABBIT ANTIBODY/THYROID STIMUL. HORMONE2Cleared 510(K)
- K780015THYROID STIMULATING HORMONE2Cleared 510(K)
- K772192NEONATAL TSH RIA KIT (125I)2Cleared 510(K)
- K772109IN VITRO HUMAN TSH RIA TEST2Cleared 510(K)
- K771767SERALUTE TSH (RIA)2Cleared 510(K)
- K771378NEO TSH-RIA KIT2Cleared 510(K)
- K771234TSH RIA REAGENT SET2Cleared 510(K)
- K771590THYROID STIMULATING HORMONE2Cleared 510(K)
- K771377THYRODOT-4, THYRODOT-SH2Cleared 510(K)
- K771222TSH RIA TEST SYSTEM2Cleared 510(K)
- K771235HTSH RIA HUMAN THYROID HORMONE RIA2Cleared 510(K)
- K770915CLASP RIA KIT, HTSH2Cleared 510(K)
- K770892TSH RADIOIMMUNOASSAY2Cleared 510(K)
- K770604RIA-DAC TM HTSH KIH2Cleared 510(K)
- K760255TEST SYSTEM, THYROID STIM. HORMONE ASSAY2Cleared 510(K)
- K760801TSH RIA KIT2Cleared 510(K)
- K760044KIT, RIA, HUMAN THYROID HORMONE2Cleared 510(K)
- K760132TEST, RIA, TSH QUANTIMUNE2Cleared 510(K)
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- JQBKinetic Method, Gamma-Glutamyl Transpeptidase1Product Code
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- KNKAcid, Uric, Uricase (Colorimetric)1Product Code
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- 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
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- 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
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- 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
- MSJApolipoproteins1Product Code
- MSMSystem, Test, Lipoprotein(A)1Product Code
- MYTBiosensor, Immunoassay, Cpk Or Isoenzymes2Product Code
- MZUSystem, Test, Sodium, Enzymatic Method2Product Code
- MZVTest, System, Potassium, Enzymatic Method2Product Code
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- NALTest, Immunoassay, Biosensor, Hcg2Product 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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Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
- Page Type
- Cleared 510(K)
- 510(k) Number
- K160541
- 510(k) Type
- Traditional
- Applicant
- SYSMEX AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/21/2016
- Days to Decision
- 238 days
- Submission Type
- Summary