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
- K241919Innovita HCG Pregnancy Rapid Combo Test2Cleared 510(K)
- K203272Alltest Pregnancy Rapid Combo Test Cassette2Cleared 510(K)
- K172322Atellica IM Total hCG (ThCG)2Cleared 510(K)
- K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)2Cleared 510(K)
- K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip2Cleared 510(K)
- K130456WUNDER PREGNANCY TEST2Cleared 510(K)
- K132834FASTEP S10 HCG SERUM/URINE COMBO TEST2Cleared 510(K)
- K131166SOFIA(R) HCG FIA2Cleared 510(K)
- K123844CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST2Cleared 510(K)
- K112101FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS2Cleared 510(K)
- K112315HOME PREGNANCY TEST2Cleared 510(K)
- K102175RAPIDVUE HCG TEST2Cleared 510(K)
- K072264FASTPACK HCG IMMUNOASSAY2Cleared 510(K)
- K071030BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC2Cleared 510(K)
- K070921BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG2Cleared 510(K)
- K061257DBEST HCG PANEL TEST KIT2Cleared 510(K)
- K062361INNOVACON HCG UKTRA TEST DEVICE2Cleared 510(K)
- K050955LIFESIGN DXPRESS, MODEL LSR20002Cleared 510(K)
- K052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.2Cleared 510(K)
- K051841WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST2Cleared 510(K)
- K050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT2Cleared 510(K)
- K043385OSOM HCG COMBO TEST2Cleared 510(K)
- K041946ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE2Cleared 510(K)
- K041728HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE2Cleared 510(K)
- K033297ZAP HCG TEST, MODEL 80012Cleared 510(K)
- K032563CLINITEST HCG PREGNANCY TEST2Cleared 510(K)
- K032987ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-0052Cleared 510(K)
- K031445MAINLINE MAXIE HCG URINE PREGNANCY TEST2Cleared 510(K)
- K031048CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST2Cleared 510(K)
- K023823EASYCUP2Cleared 510(K)
- K030430POLY STAT SERUM/URINE HCG TEST2Cleared 510(K)
- K023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST2Cleared 510(K)
- K023544GENZYME CONTRAST II HCG URINE/SERUM TEST2Cleared 510(K)
- K023480ACCESS TOTAL BHCG2Cleared 510(K)
- K022683SAS BLOOD/SERUM/URINE/URINE HCG2Cleared 510(K)
- K021386POLY STAT HCG DIPSTICK TEST2Cleared 510(K)
- K020968LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD2Cleared 510(K)
- K020378QUPID PLUS E.R.2Cleared 510(K)
- K020439STATUS HCG SERUM/URINE2Cleared 510(K)
- K020801QUICKVUE ONE-STEP HCG-COMBO2Cleared 510(K)
- K020799QUICKVUE ONE-STEP HCG-URINE2Cleared 510(K)
- K020438SAS VALUE HCG2Cleared 510(K)
- K020128ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-85002Cleared 510(K)
- K013702VICTORCH HCG TEST STRIP2Cleared 510(K)
- K012559POLY STAT HCG TEST2Cleared 510(K)
- K013194UNIMARK HCG COMBO PREGNANCY TEST2Cleared 510(K)
- K012284WH ACCU TEST PREGNANCY TEST2Cleared 510(K)
- K011550HCG STAT PAK ULTRA-FAST2Cleared 510(K)
- K010522SUREVUE URINE HCG2Cleared 510(K)
- K010593SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT2Cleared 510(K)
- K003856EZ-HCG URINE(PREGNANCY TEST)2Cleared 510(K)
- K001215DBEST HCG 2 IU/ML TEST KIT2Cleared 510(K)
- K994227ADVANTAGE HCG TEST (URINE/SERUM)2Cleared 510(K)
- K993703CLEARVIEW EASY HCG PREGNANCY TEST2Cleared 510(K)
- K993317ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)2Cleared 510(K)
- K993203ACON ONE STEP PREGNANCY TEST STRIP (URINE)2Cleared 510(K)
- K992915ONE-STEP DOUBLE-CHEK PREGNANCY TEST2Cleared 510(K)
- K992695INSURE PRO TEST2Cleared 510(K)
- K993065ACON COMBO PREGNANCY2Cleared 510(K)
- K992397ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE2Cleared 510(K)
- K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10272Cleared 510(K)
- K990741SAS ONE-STEP PREGNANCY2Cleared 510(K)
- K990684MODIFICATION OF SAS SERUM/URINE HCG2Cleared 510(K)
- K991095QUICKCARD HCG COMBO TEST, MODEL #90142Cleared 510(K)
- K991067MODIFICATION OF: DAVIDSTRIP HCG2Cleared 510(K)
- K990578OSOM CARD II HCG-URINE TEST, MODEL 1022Cleared 510(K)
- K984080INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST2Cleared 510(K)
- K984076INSTANT-VIEW PREGNANCY URINE TEST2Cleared 510(K)
- K984077INSTANT-VIEW PREGNANCY COMBO TEST2Cleared 510(K)
- K984079INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST2Cleared 510(K)
- K981444BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP2Cleared 510(K)
- K981838ACCUSTRIP HCG-URINE MODEL NUMBER HCG-0022Cleared 510(K)
- K981443BIOSIGN HCG I - ONE STEP PREGNANCY TEST2Cleared 510(K)
- K981770RAPIDHCG PREGNANCY TEST2Cleared 510(K)
- K981512ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 410252Cleared 510(K)
- K981165AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST2Cleared 510(K)
- K980736ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST2Cleared 510(K)
- K974060MINISTRIP/ SERUM AND URINE COMBO HCG TEST2Cleared 510(K)
- K980896QUICKCARD PRO HCG TEST, MODEL 90082Cleared 510(K)
- K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 335052Cleared 510(K)
- K974009PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG2Cleared 510(K)
- K980531AIMSTEP PREGNANCY2Cleared 510(K)
- K980205SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST2Cleared 510(K)
- K974615QUICKSTICK PRO HCG TEST2Cleared 510(K)
- K974851SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST2Cleared 510(K)
- K974159OSOM HCG-URINE TEST MODEL 1012Cleared 510(K)
- K974052QUICKVUE SEMI-Q HCG-COMBO2Cleared 510(K)
- K973957DBEST ONE-STEP HCG SERUM/URINE TEST2Cleared 510(K)
- K973841QUICKVUE ONE-STEP HCG-COMBO2Cleared 510(K)
- K973858CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO2Cleared 510(K)
- K973879OSOM CARD HCG-URINE TEST2Cleared 510(K)
- K972748CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE2Cleared 510(K)
- K972742QUICKVUE ONE-STEP HCG-URINE2Cleared 510(K)
- K971886ACCUTEST HCG-URINE2Cleared 510(K)
- K971122ACCULINE PREGNANCY TEST2Cleared 510(K)
- K971209CLINITEK HCG TEST STRIPS2Cleared 510(K)
- K970424EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST2Cleared 510(K)
- K965116ABBOTT TESTPACK PLUS HCG COMBO WITH OBC2Cleared 510(K)
- K964633ACCUPACK PREGNANCY TEST2Cleared 510(K)
- K965250SAS SERUM/URINE HCG2Cleared 510(K)
- K965253SAS PREGNANCY STRIP2Cleared 510(K)
- K964536ONE-STEP DIPSTICK PREGNANCY TEST2Cleared 510(K)
- K964461ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST2Cleared 510(K)
- K964462ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST2Cleared 510(K)
- K965227OSOM CLASSIC HCG-URINE TEST (115)2Cleared 510(K)
- K964995SAS ONE-STEP PREGNANCY2Cleared 510(K)
- K964574AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST2Cleared 510(K)
- K963231EXCEL ONESTEP URINE HCG MODULE PREGNANCY TEST2Cleared 510(K)
- K964156CONTRAST STRIP HCG2Cleared 510(K)
- K964155CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST2Cleared 510(K)
- K963132MINI STRIP/SERUM HCG2Cleared 510(K)
- K963133PS-UNIT CASSETTE/SERUM HCG2Cleared 510(K)
- K963408VISUALINE D HCG2Cleared 510(K)
- K962906SCRIPPS LABORATORIES HCG ONE-STEP2Cleared 510(K)
- K954065BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K961911DSL ACTIVE I-HCG ELISA2Cleared 510(K)
- K960357DSL ACTIVE I-HCG IRMA2Cleared 510(K)
- K960992BIONIKE A/Q PREGNANCY TEST2Cleared 510(K)
- K955353ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT2Cleared 510(K)
- K955266ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT2Cleared 510(K)
- K953486MIT ONE STEP PREGNANCY TEST2Cleared 510(K)
- K954993QUIX RAPID PREGNANCY STRIP TEST2Cleared 510(K)
- K954901BIONIKE A/Q PREGNANCY TEST2Cleared 510(K)
- K954732ACCESS TOTAL BHCG ASSAY (MODIFICATION)2Cleared 510(K)
- K954273CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG2Cleared 510(K)
- K954029TESTPACK PLUS HCG URINE2Cleared 510(K)
- K951705MINISTRIP HCG2Cleared 510(K)
- K953383WYNTEK OSOM HCG-URINE TEST2Cleared 510(K)
- K952319CONTRAST & RAPID HCG URINE/SERUM TST2Cleared 510(K)
- K951136BIONIKE A/Q PREGNANCY TEST2Cleared 510(K)
- K943859QUICK CHECKER HCG PREGNANCY TEST2Cleared 510(K)
- K945951QUIKPAC II, ONE STEP HCG COMBO KIT2Cleared 510(K)
- K945969RAPIDVUE(TM) HCG2Cleared 510(K)
- K943239VISUALINE II HCG2Cleared 510(K)
- K944426BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE2Cleared 510(K)
- K942464UC QIK 1-STEP HCG TEST2Cleared 510(K)
- K935673AXSYM TOTAL B-HCG2Cleared 510(K)
- K936031ONE STEP PREGNANCY TEST2Cleared 510(K)
- K936287KODAK SURECELL HCG URINE TEST, MODIFICATION2Cleared 510(K)
- K936138KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION2Cleared 510(K)
- K935502EVENT TEST STRIP HCG2Cleared 510(K)
- K931698KINGS BAY PRELUDE ONE STEP HCG COMBO KIT2Cleared 510(K)
- K932758MEDIX BIOTECH BESTEST HCG-URINE TEST KIT2Cleared 510(K)
- K932279OPUS(R) TOTAL B-HCG TEST SYSTEM2Cleared 510(K)
- K932042QUICKVUE ONE-STEP HCG COMBO2Cleared 510(K)
- K925303PRO-STEP PT HCG2Cleared 510(K)
- K931302SAS PREGNANCY STRIP2Cleared 510(K)
- K926500UC QIK PREGNANCY TEST2Cleared 510(K)
- K924673CLEARVIEW HCG2Cleared 510(K)
- K930014PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST2Cleared 510(K)
- K925277CIBA CORNING ACS HCG IMMUNOASSAY2Cleared 510(K)
- K926356PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG2Cleared 510(K)
- K926342VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY2Cleared 510(K)
- K926198ACCESS TOTAL BHCG ASSAY2Cleared 510(K)
- K926204SAS ONE STEP PREGNANCY2Cleared 510(K)
- K925125PRO-STEP HCG2Cleared 510(K)
- K923925HCG STAT-PAK2Cleared 510(K)
- K925435QUICKVUE ONE-STEP HCG TEST2Cleared 510(K)
- K924259MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H01002Cleared 510(K)
- K923376VISUAL HCG PREGNANCY TEST2Cleared 510(K)
- K923030ANI BIOCARD HCG TEST2Cleared 510(K)
- K923123HCG PREGNANCY ONE STEP TEST STRIP2Cleared 510(K)
- K922697DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD2Cleared 510(K)
- K921302VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM2Cleared 510(K)
- K922290SINGLE-STEP PREGNANCY, HCG TEST2Cleared 510(K)
- K921211NOW PREGNANCY TEST KIT2Cleared 510(K)
- K921212MIRCO ELISA HPL TEST KIT2Cleared 510(K)
- K920918TMB CHROMOGEN/SUBSTRATE REAGENT SET2Cleared 510(K)
- K920505AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR2Cleared 510(K)
- K920253MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT2Cleared 510(K)
- K915701KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION2Cleared 510(K)
- K915197PRECISE TM HCG2Cleared 510(K)
- K915200PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA2Cleared 510(K)
- K914696MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF40112Cleared 510(K)
- K914240CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF2Cleared 510(K)
- K914303TARGET(TM)-HOG2Cleared 510(K)
- K914253PROCLINIC ONE STEP PREGNANCY TEST2Cleared 510(K)
- K913122DIRECTIGEN 1-2-3(TM) HCG TEST2Cleared 510(K)
- K911826IMMUNOCARD HCG ONE STEP (I-S) TEST KIT2Cleared 510(K)
- K912535IMX TOTAL B-HCG2Cleared 510(K)
- K912534IMX HCG2Cleared 510(K)
- K911047OBA(TM) SERUM HCG ASSAY2Cleared 510(K)
- K905741CLEARVIEW HCG SERUM/URINE2Cleared 510(K)
- K910349IMMUNOCORP COATED TUBE IRMA HCG2Cleared 510(K)
- K910420BIOCLONE'S ELEGANCE HCG ELISA KIT2Cleared 510(K)
- K903937TARGET(TM) HOG ONE STEP2Cleared 510(K)
- K904016MAXI TEST2Cleared 510(K)
- K904123CIBA CORNING ACS HCG IMMUNOASSAY2Cleared 510(K)
- K903219ABBOTT TESTPACK PLUS TM HCG-COMBO2Cleared 510(K)
- K902720AFFINITY HCG TEST SYSTEM2Cleared 510(K)
- K902681EZ-SCREEN:HCG2Cleared 510(K)
- K902136KODAK SURECELL(TM) HCG-URINE TEST KIT2Cleared 510(K)
- K901935OPUS (TM) HCG2Cleared 510(K)
- K901011BIOSIGN HCG-ONE STEP PREGNANCY TEST2Cleared 510(K)
- K901484LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC2Cleared 510(K)
- K900327IMX HCG (LIST #03A63)2Cleared 510(K)
- K901045HCG SOLID PHASE COMPONENT SYSTEM2Cleared 510(K)
- K896587MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT2Cleared 510(K)
- K896901ENZYMUN TEST R HCG2Cleared 510(K)
- K894175SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY2Cleared 510(K)
- K895912IMMUNOCARD HCG II-S TEST KIT2Cleared 510(K)
- K895809MILENIA(TM) HCG (MKCG1,5)2Cleared 510(K)
- K895390CARDS O.S. (TM) HCG-URINE2Cleared 510(K)
- K894941COAT-A-COUNT (TM) HCG IRMA2Cleared 510(K)
- K894790QUIDEL HCG TEST2Cleared 510(K)
- K894750BIOSTIX I. HCG - ONE STEP PREGNANCY TEST2Cleared 510(K)
- K894705BIOSPOT HCG-RAPID PREGNANCY TEST2Cleared 510(K)
- K894420ORTHO RESULT PLUS/PREGNANCY2Cleared 510(K)
- K894182IMX TOTAL B-HCG2Cleared 510(K)
- K894408ABBOTT TESTPACK PLUS HCG URINE2Cleared 510(K)
- K894012MINICLINIC PREGNANCY TEST2Cleared 510(K)
- K891770HCG IRMA II2Cleared 510(K)
- K890615DIRECTIGEN1-2-3 BHCG PREGNANCY TEST2Cleared 510(K)
- K890549VENTREX COATED TUBE HCG2Cleared 510(K)
- K890131TARGET(TM) QUANTITATIVE HCG2Cleared 510(K)
- K884880PREGNAGEN(TM)2Cleared 510(K)
- K884616FIRSTDAY EARLY PREGNANCY TESTING KIT II2Cleared 510(K)
- K883927CIBA CORNING MAGIC LITE HCG IMMUNOASSAY2Cleared 510(K)
- K883777CLEARVIEW HCG2Cleared 510(K)
- K883639MODIFIED HCG IRMA KIT2Cleared 510(K)
- K882002PREGNAGEN(TM)2Cleared 510(K)
- K881015FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT2Cleared 510(K)
- K882155COTUBE HCG IRMA TEST2Cleared 510(K)
- K881806QLT ABSOLUTE URINE-HCG PREGNANCY TEST2Cleared 510(K)
- K882086QTEST(TM) PREGNANCY2Cleared 510(K)
- K881709IMMUNOCARD(TM) HCG II TEST KIT2Cleared 510(K)
- K881355AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT2Cleared 510(K)
- K881595QUIDEL PREGNANCY TEST2Cleared 510(K)
- K881005IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG2Cleared 510(K)
- K880410HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT2Cleared 510(K)
- K880070ABBOTT IMX HCG2Cleared 510(K)
- K880577CONCEP-7-BHCG2Cleared 510(K)
- K874388KODAK SURECELL(TM) HCG-URINE KIT2Cleared 510(K)
- K874033IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X2Cleared 510(K)
- K874258VENTRESCREEN, HCG URINE2Cleared 510(K)
- K873788CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-75042Cleared 510(K)
- K872730RESULT PLUS/HCG PREGNANCY TEST2Cleared 510(K)
- K873524AFFINITY HCG IMMUNIT (POLYCLONAL)2Cleared 510(K)
- K873033HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE2Cleared 510(K)
- K872390ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM2Cleared 510(K)
- K872728BINAX IRMA TOTAL BETA-HCG TEST KIT2Cleared 510(K)
- K872130ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES2Cleared 510(K)
- K871700HCG MAB SOLID PHASE COMPONENT SYSTEM2Cleared 510(K)
- K871308ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT2Cleared 510(K)
- K871235TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT2Cleared 510(K)
- K870627AFFINITY (TM) HCG IMMUNIT (TM)2Cleared 510(K)
- K870739ABBOTT TESTPACK HCG COMBO2Cleared 510(K)
- K870751SYNTRON BIORESEARCH EZ CHECK HCG PREGNANCY TEST2Cleared 510(K)
- K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAY2Cleared 510(K)
- K870672ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD2Cleared 510(K)
- K870106COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS2Cleared 510(K)
- K864174UBIMAGIWEL(TM)HCG QUANTITATIVE AND QUALITATIVE2Cleared 510(K)
- K870259VIS-CUBE HCG (EIA) LYOPHILIZED JPL-0442Cleared 510(K)
- K865057TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY2Cleared 510(K)
- K865076SYNTRON BIORESEARCH MICROCHECK HCG PREGNANCY TEST2Cleared 510(K)
- K864591HCG SOLID PHASE COMPONENT SYSTEM2Cleared 510(K)
- K863933VIS-CUBE HCG (EIA)2Cleared 510(K)
- K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA2Cleared 510(K)
- K863199CARDS(TM) HCG-URINE2Cleared 510(K)
- K863032ABBOTT TESTPACK (TM) HCG SERUM2Cleared 510(K)
- K862262HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS2Cleared 510(K)
- K862247TARGET HCG, ENZYME IMMUNOASSAY REAGENTS2Cleared 510(K)
- K862007HCG IRMA, CAT. NO. CR-15012Cleared 510(K)
- K860965BETA QUIK STICK2Cleared 510(K)
- K860542TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT2Cleared 510(K)
- K860490MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY2Cleared 510(K)
- K854958HCG RIA TEST SYSTEM2Cleared 510(K)
- K854989CANWEST-PREGBLUE2Cleared 510(K)
- K854059MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO2Cleared 510(K)
- K854611RAMP URINE HCG ASSAY2Cleared 510(K)
- K854104IMMUCHEM V.I.P.(VISUAL INDICATED PREGNANCY)2Cleared 510(K)
- K852760LBK 1244 DELFIA HCG KIT2Cleared 510(K)
- K853925QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA2Cleared 510(K)
- K854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAY2Cleared 510(K)
- K853748VENTRESCREEN HCG URINE2Cleared 510(K)
- K853258BETA-HCG MICROTITER PREGNANCY TEST2Cleared 510(K)
- K853539ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT2Cleared 510(K)
- K853006HUMAN CHORIONIC GONAD TEST SYS FOR EARLY PREGNANCY2Cleared 510(K)
- K852327BETA QUIK STAT2Cleared 510(K)
- K852675AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT2Cleared 510(K)
- K852437VISUAL SERUM/URINE HCG COMBO KIT2Cleared 510(K)
- K852183BETA HCG EXTENDED RANGE ACCESSORY KIT2Cleared 510(K)
- K852201ECHOCLONAL HCG IRMA2Cleared 510(K)
- K850727BHCG-ROCHE EIA2Cleared 510(K)
- K851076UBI HCG-MAGIWELL EIA EARLY PREGNANCY TEST2Cleared 510(K)
- K850992PREGNA-ZYME2Cleared 510(K)
- K850949MEDIX VISUAL URINE HCG (7/7) TEST2Cleared 510(K)
- K850987MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM2Cleared 510(K)
- K850730MODEL SERUM HCG ASSAY2Cleared 510(K)
- K850570STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY2Cleared 510(K)
- K850531LEECO CONCEP-7-BHCG EIA2Cleared 510(K)
- K850530LEECO CONCEP-7-BHCG IRMA2Cleared 510(K)
- K850201LEECO CONCEP-7-BHCG LEIAD II2Cleared 510(K)
- K850159TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT2Cleared 510(K)
- K844153CONCEP-7-BHCG (EIA)2Cleared 510(K)
- K844082QUEST BETA HCG ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K843795BETA QUIK V2Cleared 510(K)
- K843407ENCORE HCG REAGENT2Cleared 510(K)
- K842654EPSILON HCG TEST KIT MONOCLONAL2Cleared 510(K)
- K842499NMS 1043 ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K842692QUIDEL BETA HCG ENZYME IMMUNOASSAY KIT2Cleared 510(K)
- K842633TANDEM FAST VISUAL HCG ASSAY KIT -2Cleared 510(K)
- K842598STAR HCG MONOCLONAL ANTIBODY IMMUNO2Cleared 510(K)
- K841854BHCG RIA2Cleared 510(K)
- K841821CA-1511, IN VITRO RADIOIMMUNOASSAY2Cleared 510(K)
- K841525OREIA II B-HCG PREGNANCY TEST KIT2Cleared 510(K)
- K841081VENTREZYME BETA-HCG IMMUNOASSAY HCG2Cleared 510(K)
- K841023COATED TUBE HCG IMMUNOASSAY HCG2Cleared 510(K)
- K840328PHASE II HCG KIT2Cleared 510(K)
- K833851HCG RIA2Cleared 510(K)
- K834000TANDEM VISUAL HCG IMMUNOENZYMETRIC2Cleared 510(K)
- K833960VENTREX PREGNANCY TEST KIT ENZYME2Cleared 510(K)
- K832796STAR HCG MONOCLONAL ANTIBODY IMMUNORAD2Cleared 510(K)
- K833194TANDEM R-TOTAL B-GCG KIT2Cleared 510(K)
- K832801OREIA II B-HCG, ENZYME INNUNOASSAY2Cleared 510(K)
- K832892MODIFIED CHORIO-SHURE2Cleared 510(K)
- K832562SERUM HCG ASSAY2Cleared 510(K)
- K831604HCG ACCU-STICK2Cleared 510(K)
- K831302PBI BHCG RIA KIT2Cleared 510(K)
- K831264BHCG RIA KIT2Cleared 510(K)
- K831223BETA-QUIK-15 RIA KIT2Cleared 510(K)
- K831221RIAGEN B-HCG RIA KIT2Cleared 510(K)
- K831109DUOCLON SLIDE TEST2Cleared 510(K)
- K830997ARIA II I-HCG2Cleared 510(K)
- K830526B-GCG SYSTEM BY RIA2Cleared 510(K)
- K830695BETA-COTE B-HCG PREGNANCY SCREENING SYS2Cleared 510(K)
- K830203DAC-CEL DIAGNATAL RD 502Cleared 510(K)
- K830138TANDEM E GCG VISUAL END POINT INNUMOENZ2Cleared 510(K)
- K823753GENESIS B-HCG2Cleared 510(K)
- K823313IN VITRO GAMMACOAT B-HCG RADIO. TEST2Cleared 510(K)
- K822840RADIOIMMUNOASSAY, HUMAN CHORRIONIC2Cleared 510(K)
- K822520MODEL UCG ASSAY2Cleared 510(K)
- K822515B-HCG RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K822343B-HCG2Cleared 510(K)
- K822152HCG BETA RIA KIT2Cleared 510(K)
- K821944TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT2Cleared 510(K)
- K821657RIAGEN B-HCG RIA2Cleared 510(K)
- K821234RIAGEN B-HCG RIA2Cleared 510(K)
- K821031AMERLEX B-LCG RIA KIT2Cleared 510(K)
- K820942ROCHE(R) B-HCG RIA URINE STANDARD2Cleared 510(K)
- K820822TANDEM HCG KIT2Cleared 510(K)
- K820614ROCHE B-HCG STANDARDS2Cleared 510(K)
- K820613ROCHE B-HCG RIA2Cleared 510(K)
- K820523CHORIO-QUANT2Cleared 510(K)
- K820321IMMOPHASE B HCG RADIOIMMUNOASSAY2Cleared 510(K)
- K820271ABBOTT LABORATORIES B-HCG EIA2Cleared 510(K)
- K812461TANDEM QUALITATIVE HCG KIT2Cleared 510(K)
- K812156CONCEP-7-BHCG2Cleared 510(K)
- K811421HCG RADIOIMMUNOASSAY KIT (125I)2Cleared 510(K)
- K811398EARLY PREGNANCY DETECTION2Cleared 510(K)
- K811116HCG RADIOIMMUNOASSAY2Cleared 510(K)
- K810936CHORIO-SHURE2Cleared 510(K)
- K810215DAC-CEL HCG2Cleared 510(K)
- K810214DAC-CEL DIAGNATAL2Cleared 510(K)
- K802999BETA-TEC QUALITATIVE2Cleared 510(K)
- K801491MRI HCG-BETA RIA KIT CAT. #MR-101002Cleared 510(K)
- K801409GAMMADAB B-HCG RADIOIMMUNOASSAY KIT2Cleared 510(K)
- K801244ROCHE HCG STANDARDS2Cleared 510(K)
- K792308CONCEP-7-BHCG2Cleared 510(K)
- K792197HUMAN CHORIONIC GONADOTROPIN (RIA)2Cleared 510(K)
- K791206HCG RIA PREGNANCY TEST2Cleared 510(K)
- K790876LABELED HUMAN CHORIONIC GONADOTROPHIN2Cleared 510(K)
- K790864RABBIT ANTISERUM TO HUMAN CHORIONIC2Cleared 510(K)
- K790863HUMAN CHORIONIC GONADOTROPHIN STANDARDS2Cleared 510(K)
- K790397CONCEP-7-B-HCG2Cleared 510(K)
- K790138CHORIC-SHURE2Cleared 510(K)
- K781794BETA-TEC2Cleared 510(K)
- K781733RIA KIT, PREG-STAT2Cleared 510(K)
- K781487EARLY PREGNANCY DETECTION KIT2Cleared 510(K)
- K781578RIA QUANT B-HCG TEST KIT2Cleared 510(K)
- K781310HUMAN CHORIONIC GONADO.-BETA RIA KIT2Cleared 510(K)
- K780679B-HCG-RIA2Cleared 510(K)
- K772086QUANTROLS HCG2Cleared 510(K)
- K772039BETA-HCG RIA2Cleared 510(K)
- K760336BIOCEPT-G2Cleared 510(K)
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- 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
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- JITCalibrator, Secondary2Product Code
- JIWCalibrator, Surrogate2Product Code
- JIXCalibrator, Multi-Analyte Mixture2Product Code
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- JIZAtomic Absorption, Iron (Non-Heme)1Product Code
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- 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
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- JJWUrinalysis Controls (Assayed And Unassayed)1Product Code
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- JJYMulti-Analyte Controls, All Kinds (Assayed)1Product Code
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- 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
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- JKRRadioimmunoassay, Calcitonin2Product Code
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- JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), Chymotrypsin1Product Code
- JKYOxalydihydrazide (Spectroscopic), Copper1Product Code
- JKZDiethyldithiocarbamate (Colorimetric), Copper1Product Code
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- JLBAtp And Creatine Kinase (Enzymatic), Creatine1Product Code
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- JLERadioimmunoassay, Desoxycorticosterone1Product Code
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- JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)1Product Code
- JMRImmunochemical, Lysozyme (Muramidase)1Product Code
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- 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
- 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
- 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
- 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
- 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
- NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).1Product Code
- 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
- 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
- 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
- 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
- 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
- DentalReview Panel
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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
AFFIRM ONE-STEP PROFESSIONAL PREGNANCY TEST
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K964574
- 510(k) Type
- Traditional
- Applicant
- ATHENA MEDICAL CORP.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/21/1997
- Days to Decision
- 68 days
- Submission Type
- Summary