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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
CIBA CORNING ACS;180 DPD ASSAY (K963251)Ciba Corning Diagnostics Corp.1996-10-15
SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (K963538)Sigma Diagnostics, Inc.1996-10-11
SIGMA DIAGNOSTICS CALICIUM REAGENT (K963536)Sigma Diagnostics, Inc.1996-10-10
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) (K962464)Scantibodies Laboratory, Inc.1996-10-08
BIO-CSF LIQUID CONTROL LEVEL 1 AND 2 (K963551)Biocell Laboratories, Inc.1996-10-07
MANUAL PHENYLALANINE TEST (K963040)Bio-Rad1996-10-01
EVIDENCE PREGNANCY TEST (K962721)Saliva Diagnostic Systems1996-10-01
SIGMA DIAGNOSTICS CREATININE REAGENT KIT (K963534)Sigma Diagnostics, Inc.1996-09-30
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT (K962033)Nichols Institute Diagnostics1996-09-27
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K963080)Bayer Corp.1996-09-27
DCA 2000 + MICROALBUMIN/CREATININE ASSAY (K963142)Bayer Corp.1996-09-27
CUSTOMED BLOOD EXTRACTION KIT (K962596)Customed, Inc.1996-09-27
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (K963540)Sigma Diagnostics, Inc.1996-09-27
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (K962890)Trace Scientific , Ltd.1996-09-27
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT (K963542)Sigma Diagnostics, Inc.1996-09-27
INCSTAR 25-HYDROXYVITMIN D 1251 RIA (K953567)Incstar Corp.1996-09-25
AMD HOME HEALTH MONITORING SYSTEM (K960337)Advanced Medical Devices, Inc.1996-09-24
AFFIRM ONE-STEP HOME PREGNANCY TEST (K962888)Athena Medical Corp.1996-09-23
HICHEM ALP/AMP REAGENT KIT (K963383)Hichem Diagnostics1996-09-23
TSH (MICROWELL) ELISA (K962216)Biomerica, Inc.1996-09-19
LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 (K961941)Bio-Rad1996-09-16
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2 (K961359)Bioprocessing, Inc.1996-09-13
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR (K962629)Casco Standards1996-09-13
THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST (K961629)Teco Diagnostics1996-09-11
DSL DHEA-S-7 (K962895)Diagnostic Systems Laboratories, Inc.1996-09-10
ELECSYS CALCHECK T UPDATE (K963181)Boehringer Mannheim Corp.1996-09-10
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 (K963346)Consolidated Technologies, Inc.1996-09-09
DSL ACTIVE FSH IRMA (K962118)Diagnostic Systems Laboratories, Inc.1996-09-09
GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (K955770)Abaxis, Inc.1996-09-09
GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 (K960860)Greiner America, Inc.1996-09-05
ELECT BLOOD GLUCOSE MONITORIG SYSTEM (K961985)Selfcare, Inc.1996-09-05
LFS LIPOGEL ASSAY KIT (K960785)Zaxis, Inc.1996-09-03
DSL 9100 IGF-II IRMA (K962758)Diagnostic Systems Laboratories, Inc.1996-08-30
VIDAS CREATINE KINASE MB ASSAY 30-421 (K962549)Biomerieux Vitek, Inc.1996-08-30
GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR (K960857)Greiner America, Inc.1996-08-30
ELECSYS CALCHECK HCG (K963165)Boehringer Mannheim Corp.1996-08-30
GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR (K960858)Greiner America, Inc.1996-08-30
COBAS CORE IMMUNOCHEMISTRY SYSTEM (K962231)Roche Diagnostic Systems, Inc.1996-08-30
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) (K962975)Diagnostic Products Corp.1996-08-29
EZ SURE ONESTEP EARLY PREGNANCY TEST (K962580)Excel Scientific, Inc.1996-08-29
IMMULITE ACTH CONTROL MODULE (LACCM) (K963240)Diagnostic Products Corp.1996-08-29
ELECSYS CALCHECK FT4 (K963164)Boehringer Mannheim Corp.1996-08-27
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 (K955880)Diagnostic Chemicals , Ltd.1996-08-27
ELECSYS CALCHECK FT3 (K963163)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK T4 (K963178)Boehringer Mannheim Corp.1996-08-27
IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25 (K961587)Diagnostic Chemicals , Ltd.1996-08-27
ELECYS CALCHECK T 3 (K963167)Boehringer Mannheim Corp.1996-08-27
ELECSYS CALCHECK TROPONIN T (K963143)Boehringer Mannheim Corp.1996-08-23
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (K962875)Diagnostic Systems Laboratories, Inc.1996-08-23
OPUS HLH (K962866)Behring Diagnostics, Inc.1996-08-23
HEMOCUE B-GLUCOSE SYSTEM (K961311)Hemocue, Inc.1996-08-23
ELECSYS CALCHECK CK-MB (K963182)Boehringer Mannheim Corp.1996-08-23
ELECSYS CALCHECK TSH (K963147)Boehringer Mannheim Corp.1996-08-23
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT (K962982)Nova Biomedical Corp.1996-08-23
SCRIPPS LABORATORIES HCG ONE-STEP (K962906)Scripps Laboratories, Inc.1996-08-23
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (K963005)Nova Biomedical Corp.1996-08-23
IMMAGE IMMUNOCHEMISTRY SYSTEM (K962294)Beckman Instruments, Inc.1996-08-21
BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS (K961792)Biocircuits Corp.1996-08-21
UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY (K963116)Diagnostic Chemicals , Ltd.1996-08-20
LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III (K963085)International Enzymes, Inc.1996-08-20
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573)Hybritech, Inc.1996-08-19
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR (K962186)Genzyme Corp.1996-08-19
SAFESTRIP (K955107)Firehouse Medical, Inc.1996-08-16
MICROLAB 4000, MICROLAB 4200 (K961896)Hamilton Co.1996-08-16
ACTIVE ANDROSTENEDIONE EIA (K963002)Diagnostic Systems Laboratories, Inc.1996-08-16
TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60 (K961281)Diagnostic Chemicals , Ltd.1996-08-16
RADIAS PHENYLALANINE TEST (K960437)Bio-Rad1996-08-16
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR (K962762)Biotraces, Inc.1996-08-16
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET (K961912)Consolidated Technologies, Inc.1996-08-15
OPUS MYOGLOBIN CONTROLS (K962841)Behring Diagnostics, Inc.1996-08-15
ACA PLUS FREE THYROXINE(FT4) METHOD (K962602)Dade Intl., Inc.1996-08-15
HICHEM CK/NAC REAGENT KIT (K962247)Elan Pharma, Inc.1996-08-15
ACA PLUS FT4 CALIBRATOR (K962594)Dade Intl., Inc.1996-08-15
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3 (K962997)Nova Biomedical Corp.1996-08-15
ELECSYS T3 (K962508)Boehringer Mannheim Corp.1996-08-15
TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (K961477)Trace America, Inc.1996-08-05
HEPATITIS NEGATIVE CONTROL (K962399)Pyramid Biological Corp.1996-08-02
CBI 7520 READER (K961183)Columbia Bioscience, Inc.1996-08-02
TECHNICON IMMUNO 1 SYSTEM (K962125)Bayer Corp.1996-08-02
ORIGEN ANALYZER (K962166)Igen, Inc.1996-07-31
FACTPLUS ONE STEP PREGNANCY TEST (K962521)Direct Access Diagnostics1996-07-29
PRECISION QID BLOOD GLUCOSE TEST STRIP (K962295)Medisense, Inc.1996-07-26
CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) (K960800)Boehringer Mannheim Corp.1996-07-26
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (K954968)Tcpi, Inc.1996-07-26
STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (K954326)Solarcare Technologies Corp,Inc.1996-07-23
CHEMCARD GLUCOSE TEST (K943503)Chem-Elec, Inc.1996-07-23
QUICKSTICK ONE STEP PREGNANCY TEST(9010) (K962219)Phamatech1996-07-23
URIC ACID-SL ASSAY CATALOGUE NO. 237-60 (K961586)Diagnostic Chemicals , Ltd.1996-07-23
ELECSYS PRECICONTROL CARDIAC (K962575)Boehringer Mannheim Corp.1996-07-22
ELECSYS TSH ASSAY (K961491)Boehringer Mannheim Corp.1996-07-22
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (K954156)Solarcare Technologies Corp,Inc.1996-07-22
DOCUMENT CARDIAC ASSAYED CONTROL (K961750)Casco Standards1996-07-22
OPUS B12 CONTROLS (K962694)Behring Diagnostics, Inc.1996-07-22
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (K962574)Waters Corporation1996-07-22
URITEST - NITRITE IN URINE TEST (K954685)Tcpi, Inc.1996-07-22
ELECSYS PRECICONTROL TSH (K962573)Boehringer Mannheim Corp.1996-07-22
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL (K962630)Casco Standards1996-07-22
SENTINEL LIPASE LIQUID MODEL 17.401B (K961179)Equal Diagnostics, Inc.1996-07-19
HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT (K960029)Morax1996-07-17
N CRP STANDARD SY (K962406)Behring Diagnostics, Inc.1996-07-16
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