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Clinical Chemistry

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

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RecordFirmDate
LIQUISPEX(TM) URINE ETHANOL CONTROL (K946144)Clinical Controls, Inc.1995-02-08
QUIKPAC II, ONE STEP HCG COMBO KIT (K945951)Syntron Bioresearch, Inc.1995-02-08
TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II (K940817)Abbott Laboratories1995-02-08
UREA NITROGEN REAGENT (K944250)Olympus Corp of America1995-02-08
WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR (K944664)Wako Chemicals USA, Inc.1995-02-07
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (K945458)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-02-06
CERES 900C & CERES UV900C (K942923)Bio-Tek Instruments, Inc.1995-02-06
CHEMSPEX(TM) AMMONIA CONTROL (K946143)Clinical Controls, Inc.1995-02-03
RADIAS RED CELL FOLATE IMMUNOASAY (K944212)Bio-Rad1995-02-03
BLOOD KIT, SEXUAL ASSAULT KIT (K945245)Lynn Peavey Co.1995-02-01
CIBA CORNING 8-- SERIES CO-OXIMETER (K946206)Ciba Corning Diagnostics Corp.1995-01-30
CERTAIN(R) ELITE LEVEL 1, 2 AND 3 (K946224)Ciba Corning Diagnostics Corp.1995-01-30
DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER (K943493)Hamilton Co.1995-01-30
RAPIDVUE(TM) HCG (K945969)Quidel Corp.1995-01-27
ADVANCE(R) PREGNANCY TEST (K945846)Advanced Care Products1995-01-27
CHOLESTEROL QVET (K943027)Prisma Systems1995-01-27
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION (K946146)Clinical Controls, Inc.1995-01-24
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL (K946145)Clinical Controls, Inc.1995-01-24
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE (K945952)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-01-18
KODAK EKTACCHEM 950IRC ANALYZER (K946090)Clinical Diagnostic Systems, Inc.1995-01-17
HEMOCUE B-GLUCOSE SYSTEM (K943432)Hemocue, Inc.1995-01-17
SPECTRUM CO-OXIMETER LINEARITY CONTROL (K945860)Phoenix Diagnostics, Inc.1995-01-17
GLUCOCHEK (K940215)Clinical Diagnostics, Inc.1995-01-17
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (K945718)Casco Standards1995-01-17
MODEL 2721 CLINICAL REFRACTOMETER (K941901)Vee Gee Scientific, Inc.1995-01-17
MODEL 2730 CLINICAL REFRACTOMETER (K941906)Vee Gee Scientific, Inc.1995-01-17
QUANITITATE GBCC VERIFIER SET (K944454)Beckman Instruments, Inc.1995-01-17
SAS QUANT HCG SERUM (K944785)Sa Scientific, Inc.1995-01-17
CEDIA(R) FOLATE (NO BOIL) ASSAY (K946184)Microgenics Corp.1995-01-17
AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (K942661)Sealite Sciences, Inc.1995-01-17
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) (K944455)Beckman Instruments, Inc.1995-01-17
EASY LYTE CALCIUM ANALYZER (K943091)Medica Corp.1995-01-17
MODEL 2740 CLINICAL REFRACTOMETER (K941903)Vee Gee Scientific, Inc.1995-01-17
HCG MIDSTREAM PREGNANCY TEST (K945568)Mizuho USA, Inc.1995-01-17
PLATO 3300/1300 (K943454)Rosys, Inc.1995-01-09
IRMA BLOOD ANALYSIS SYSTEM (K945240)Diametrics Medical, Inc.1995-01-05
CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) (K945655)Miles, Inc.1995-01-05
CALCIUM REAGENT (K944258)Olympus America, Inc.1995-01-05
STAT PROFILE ULTRA 11 ANALYZER (K943643)Nova Biomedical Corp.1994-12-29
ALKALINE PHOSPHATASE (ALKP) QVET (K942997)Prisma Systems1994-12-29
DYE CHECK STRIPS 545-630 (K943729)Awareness Technology, Inc.1994-12-29
BUN QVET (K943042)Prisma Systems1994-12-29
LACTATE DEHYDROGENASE QVET (K942964)Prisma Systems1994-12-29
MAGNESIUM QVET (K943001)Prisma Systems1994-12-29
GLUCOSE QVET (K942963)Prisma Systems1994-12-29
AQUALITE FSH (K943437)Sealite Sciences, Inc.1994-12-28
NEOSCREEN ELISA HYDROXYPROGESTERONE (K940233)Pantex1994-12-28
OLYMPUS MAGNESIUM REAGENT (K944407)Olympus America, Inc.1994-12-27
PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES (K945777)Smiths Industries Medical Systems, Inc.1994-12-22
CORVAC PLASTIC BLOOD COLLECTION TUBE (K944814)Sherwood Medical Co.1994-12-19
COAT-A-COUNT FREE ESTRIOL (K932989)Diagnostic Products Corp.1994-12-19
IMMULITE RAPID TSH (K933212)Diagnostic Products Corp.1994-12-19
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY (K935399)Bio-Rad1994-12-19
IMMULITE THIRD GENERATION (MODIFICATION) (K940006)Diagnostic Products Corp.1994-12-19
IMMULITE PROGESTERONE (K944211)Diagnostic Products Corp.1994-12-19
ABBOTT IMX 2 ANALYZER (K944731)Abbott Laboratories1994-12-19
AST QVET (K944102)Prisma Systems1994-12-13
MODEL 3461 CLINICAL REFRACTOMETER (K941905)Vee Gee Scientific, Inc.1994-12-13
ALBUMIN QVET (K943000)Prisma Systems1994-12-13
MODEL 3471 CLINICAL REFRACTOMETER (K941902)Vee Gee Scientific, Inc.1994-12-13
MODEL A300CL CLINICAL REFRACTOMETER (K941904)Vee Gee Scientific, Inc.1994-12-13
CIBA CORNING ACS FOLATE ASSAY (K943297)Ciba Corning Diagnostics Corp.1994-12-12
TOTAL PROTEIN QVET (K943004)Prisma Systems1994-12-09
IMX T3 ASSAY (K944808)Organon Teknika Corp.1994-12-09
THYROXINE ENZYME IMMUNOASSAY (K944703)Diagnostic Reagents, Inc.1994-12-09
PHOSPHATE QVET (K942960)Prisma Systems1994-12-09
AMYLASE QVET (K942961)Prisma Systems1994-12-09
POTASSIUM QVET (K943026)Prisma Systems1994-12-09
CALCIUM QVET (K943003)Prisma Systems1994-12-09
CLARIT(TM) (K945353)Advanced Biomedical Methods, Inc.1994-12-09
OLYMPUS AMYLASE REAGENT (K944229)Olympus America, Inc.1994-12-09
AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT (K944490)Wallac OY1994-12-09
MICROREADER 4 (K935983)Hyperion, Inc.1994-12-09
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (K945315)Casco Standards1994-12-09
CHLORIDE QVET (K943006)Prisma Systems1994-12-07
HDL QVET (K943028)Prisma Systems1994-12-07
GGT QVET (K942962)Prisma Systems1994-12-07
VISUALINE II HCG (K943239)Sun Biomedical Laboratories, Inc.1994-12-07
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (K945322)Emd Chemicals, Inc.1994-12-07
DMA CALCIUM PLUS PROCEDURE (K944255)Data Medical Associates, Inc.1994-12-06
BOEHRINGER MANNHEIM BICARBONATE ASSAY (K933461)Boehringer Mannheim Corp.1994-12-05
PHOSPHORUS TEST (PHOS) (K945368)Emd Chemicals, Inc.1994-12-02
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E (K944486)International Enzymes, Inc.1994-12-02
BILIRUBIN(TOTAL) QVET (K942999)Prisma Systems1994-12-02
IRON QVET (K943029)Prisma Systems1994-12-02
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) (K944452)Beckman Instruments, Inc.1994-12-02
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E (K944513)International Enzymes, Inc.1994-12-02
URIC ACID QVET (K943002)Prisma Systems1994-12-02
DOCUMENT R AMMONIA/ETHANOL CONTROL (K944361)Casco Standards1994-11-30
PROCHEM CHEMISTRY ANALYZER (K944028)Prisma Systems1994-11-30
CALIBRATOR (K943012)Prisma Systems1994-11-28
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM (K943595)Instrumentation Laboratory CO1994-11-28
ACE CEDIA CORTISOL ASSAY (K943427)Schiapparelli Biosystems, Inc.1994-11-28
QUANTITATE URIC ACID VERIFIER SET (K944453)Beckman Instruments, Inc.1994-11-22
CREATININE QVET (K943005)Prisma Systems1994-11-22
TRIGLYCERODES QVET (K942998)Prisma Systems1994-11-22
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY (K933414)Baxter Diagnostics, Inc.1994-11-22
BILIRUBIN (DIRECT) QVET (K942949)Prisma Systems1994-11-22
ALT QVET (K944080)Prisma Systems1994-11-22
CALIBRATORS (K944701)Diagnostic Reagents, Inc.1994-11-21
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