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Clinical Chemistry

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

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RecordFirmDate
ACCESS CK-MB REAGENTS (K945083)Bio-Rad Laboratories, Inc.1994-11-21
CREATINE KINASE MB DETERMINATION (UV) (K942958)Biochemical Trade, Inc.1994-11-21
SAS QUANT HCG URINE (K944891)Sa Scientific, Inc.1994-11-17
ISOSCAN (K944185)Isolab, Inc.1994-11-17
SERUM PROTEIN CONTROLS (K944515)Pyramid Biological Corp.1994-11-17
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET (K944338)Casco Standards1994-11-15
DMA IRON PROCEDURE (K944462)Data Medical Associates, Inc.1994-11-15
ANGIOTENSIN CONVERTING ENZYME REA (K942497)American Laboratory Products Co., Ltd.1994-11-15
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR (K944639)Casco Standards1994-11-15
PROCHEQ 1 & 2 (K944059)Prisma Systems1994-11-15
ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED (K944202)Abbott Laboratories1994-11-14
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE (K944566)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-11-10
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM (K944093)E.I. Dupont DE Nemours & Co., Inc.1994-11-10
REP DIRECT-SEP CHOLESTEROL-15 KIT; CHOLESTEROL-8 KIT; CHOLESTEROL-4 KIT (K935162)Helena Laboratories1994-11-10
DUPONT ACA STAR (K941050)Dupont Medical Products1994-11-10
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (K943148)Diagnostic Systems Laboratories, Inc.1994-11-10
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM (K942451)Bio-Rad1994-11-10
CHEMSTRIP MINI UA URINE ANALYZER (K943592)Boehringer Mannheim Corp.1994-11-08
CKMB/MYOGLOBIN MASS MEASUREMENY CONTROL LEVEL 1, 2, 3, (K944923)Clinical Controls, Inc.1994-11-04
SIGMA GLUCOSE REAGENT (K933694)Sigma Chemical Co.1994-11-04
SYNCHRON CX3 DELTA (K942676)Beckman-Diagnostic Systems Group1994-11-02
MR7000 WITH TIME MANAGER SOFTWARE (TMS) (K934111)Dynatech Laboratories, Inc.1994-11-02
ENZYME-LINKED FLUORESCENT IMMUNOASSAY (K943811)Biomerieux Vitek, Inc.1994-11-02
FLUIDS PACK (K944516)Alko Diagnostic Corp.1994-11-02
CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (K944247)Cala Diagnostics1994-10-31
FOLIC ACID (K943705)Diagnostic Products Corp.1994-10-31
IMMULITE SHBG (K941797)Diagnostic Products Corp.1994-10-31
ROCHE REAGENT (K941573)Roche Diagnostic Systems, Inc.1994-10-31
CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (K944246)Cala Diagnostics1994-10-31
HCG/TSH CONTROL- LEVEL 1/LEVEL 2/LEVEL 3 (K935599)Clinical Controls, Inc.1994-10-31
NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) (K943780)Heraeus Kulzer, Inc.1994-10-31
SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY (K941496)Solarcare, Inc.1994-10-27
CARDIOCHEX (K944243)Cala Diagnostics1994-10-27
PRO-STEP LH OVULATION PREDICTION TEST (K943252)Disease Detection International, Inc.1994-10-25
4 CHANNEL DISPENSER (K944556)Tecan U.S., Inc.1994-10-25
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE (K944426)Princeton BioMeditech Corp.1994-10-25
CEDIA T4 MAB ASSAY (K943019)Microgenics Corp.1994-10-20
MRX MICROPLATE READER (K943701)Dynatech Laboratories, Inc.1994-10-20
AVL OPTI PH/BLOOD GAS ANALYZER (K944089)Avl Scientific Corp.1994-10-20
SEALITE SCIENCE, INC. AQUALITE(R) LH (K943188)Sealite Sciences, Inc.1994-10-20
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD (K943996)Dupont Medical Products1994-10-20
DMA GLUCOSE (OXIDASE) PROCEDURE (K943241)Data Medical Associates, Inc.1994-10-20
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE (K941765)Tcpi, Inc.1994-10-20
SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGE (K944738)Ducker CL1994-10-19
QUANTASE PHENYLALANINE ASSAY (K922547)Porton Cambridge , Ltd.1994-10-13
VIROTROL TORCH (K942295)Blackhawk Biosystems, Inc.1994-10-07
URINARY CATECHOLAMINE KIT (K943099)Bioanalytical Systems, Inc.1994-10-07
HITACHI 914 ANALYZER (K942364)Boehringer Mannheim Corp.1994-10-04
KOVA LIQUA-TROL (K942853)Hycor Biomedical, Inc.1994-10-04
HICHEM ENZYME VERIFIER KIT (K943684)Hi Chem, Inc.1994-10-04
MULTI ANALYTE LINEARITY SET (K936245)Teco Diagnostics1994-10-04
SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (K943925)Quantimetrix Corp.1994-10-04
ELEGANCE NEONATAL TSH ELISA (K935049)Bioclone Australia Pty , Ltd.1994-10-03
DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM (K941146)Dupont Medical Products1994-10-03
UC QIK 1-STEP HCG TEST (K942464)Eucardio Laboratory, Inc.1994-09-20
CREATININE-PO REAGENT KIT (K943924)Synermed, Inc.1994-09-20
THE YELLOW IRIS (K943463)Intl. Remote Imaging Systems1994-09-20
GAMMA-BCT INTACT PTH (K942369)Immunodiagnostic Systems , Ltd.1994-09-20
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT (K943754)Bionostics, Inc.1994-09-14
LIPASE CALIBRATOR (K943704)The DU Pont Co.1994-09-14
INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT (K941807)Intersect Systems, Inc.1994-09-14
BILIRUBIN PLUS/PEDIATRIC CONTROLS (K943290)Medi-Tech, Inc.1994-09-14
OPERA SYSTEM (K943376)Miles, Inc.1994-09-14
URINE REAGENT STRIP-3 PARAMETERS (K940469)Teco Diagnostics1994-09-09
TNT TROPONIN T (K942632)Streck Laboratories, Inc.1994-09-09
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 (K940679)Helena Laboratories1994-09-09
DUPONT DIMENSION AMYLASE METHOD (K942640)Dupont Medical Products1994-09-09
AVL 988-4 ELECTROLYTE ANALYZER (K943702)Avl Scientific Corp.1994-09-09
ACCESS(R) TOTAL T3 (K940833)Bio-Rad Laboratories, Inc.1994-09-07
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT (K942638)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-09-07
OCTEIA INTACT PTH (K941878)I.D.S.1994-09-07
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT (K941168)Incstar Corp.1994-09-07
PBI PLUS HDL PRECIPITATING REAGENT (K941744)Merchant House Scientific1994-09-06
FLUIDS PACK FOR CORING 238 (K940760)Alko Diagnostic Corp.1994-09-06
DELFIA SHBG KIT (K940449)Wallac OY1994-09-06
DMA MICROPROTEIN PROCEDURE (K942424)Data Medical Associates, Inc.1994-09-06
4 CHANNEL DISPENSER (K942655)Tecan U.S., Inc.1994-09-02
ROCHE REAGENT FOR CREATININE (K941837)Roche Diagnostic Systems, Inc.1994-08-26
AURAFLEX SYSTEMS (K942443)Organon Teknika Corp.1994-08-26
ACCESS RED BLOOD CELL FOLATE ASSAY (K943149)Beckman Coulter, Inc.1994-08-26
STAR I WORKSTATION (K942290)Standard Engineering1994-08-26
CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (K942284)Creative Laboratory Products, Inc.1994-08-26
CK-MB ASSAY, CATALOGUE NUMBER 317-10 (K942773)Diagnostic Chemicals , Ltd.1994-08-24
AVL COMPACT 1 PH/BLOOD GAS ANALYZER (K943570)Avl Scientific Corp.1994-08-24
DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN (K942241)Dupont Medical Products1994-08-18
TRAK LIQUID CEREBROSPINAL FLUID CONTROL LEVELS 1 & 2 (K941328)Medical Analysis Systems, Inc.1994-08-18
SEALITE SCIENCES INC. (K941983)Sealite Sciences, Inc.1994-08-18
CARDIO REP LD (K940224)Helena Laboratories1994-08-17
DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN (K942240)Dupont Medical Products1994-08-17
IMX ULTRASENSISTIVE HTSH II (K942566)Abbott Laboratories1994-08-16
VISTA B12 ASSAY (K941235)Syva Co.1994-08-15
DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR (K941219)Dupont Medical Products1994-08-09
BIOSCAN REAGENT STRIPS (K943008)Genesis Labs, Inc.1994-08-08
AMMONIA ASSAY CAT. NO. 200-02 (K932556)Diagnostic Chemicals, Ltd. (Usa)1994-08-02
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH (K941433)Hichem Diagnostics1994-08-02
INCSTAR ACTH IRMA (K940271)Incstar Corp.1994-08-02
KINASE ISOENZYME (K943024)Dupont Medical Products1994-08-02
MICROTAINER BRAND TUBE WITH EDTA(K2) (K940905)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-08-02
MODEL 644 SWEAT DILUENT (K935228)Ciba Corning Diagnostics Corp.1994-08-01
LIQUID AMYLASE (CNPG3) REAGENT SET (K940735)Pointe Scientific, Inc.,1994-08-01
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