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Clinical Chemistry

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

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RecordFirmDate
AMYLASE (K930678)Horizon Diagnostics, Inc.1994-04-06
SYNERMED ISE REAGENTS (K940194)Synermed, Inc.1994-04-05
DOCUMENT(R) ZERO (K940568)Casco Standards1994-04-05
TMC I, II (K930534)Ciba Corning Diagnostics Corp.1994-04-04
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM (K934607)Alko Diagnostic Corp.1994-03-28
IL TEST(TM) TRIGLYCERIDE (K931116)Instrumentation Laboratory CO1994-03-28
IL1430 BGELECTROLYTE ANALYZER (K935069)Instrumentation Laboratory CO1994-03-28
ACA PLUS FERRITIN CALIBRATOR (K935543)E.I. Dupont DE Nemours & Co., Inc.1994-03-22
FERTILITY PLUS 1, 2, 3 (K935219)Ciba Corning Diagnostics Corp.1994-03-22
VIDAS T3 ASSAY (K934764)Biomerieux Vitek, Inc.1994-03-22
SERUM AMMONIA CONTROL (K935606)P.T. Meditrol1994-03-22
VIDAS T UPTAKE (K935816)Biomerieux Vitek, Inc.1994-03-22
SYNELISA DHEA-SULFATE (K935469)Elias U.S.A., Inc.1994-03-22
KODAK EKTACHEM DT SLIDES (FE) (K934358)Eastman Kodak Company1994-03-21
KODAK EKTACHEM DT SLIDES (URCR) (K934071)Eastman Kodak Company1994-03-21
URINARY ALBUMIN CALIBRATOR (K936201)Dupont Medical Products1994-03-11
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR (K934843)E.I. Dupont DE Nemours & Co., Inc.1994-03-11
CREATININE-S ASSAY (K934587)Diagnostic Chemicals , Ltd.1994-03-11
DMA AMYLASE (DEMAND) PROCEDURE (K940010)Data Medical Associates, Inc.1994-03-11
ACS O DILVENT PROTEIN DILUTION MATRIX (K940397)Analytical Control Systems, Inc.1994-03-11
SIGMA CALCIUM REAGENT (K933678)Sigma Chemical Co.1994-03-11
REAGENTS FOR HITACHI ISE (K933383)Alko Diagnostic Corp.1994-03-09
OPUS(R) SEROLOGY CONTROLS, MODIFICATION (K934137)Pb Diagnostic Systems, Inc.1994-03-07
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY (K940005)Bio-Rad Laboratories, Inc.1994-03-03
CEDIA T4 MAB ASSAY MODIFICATION (K935880)Microgenics Corp.1994-03-03
EVATEST STRIP (K936013)Boehringer Mannheim Italia Spa1994-02-25
ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (K923917)Nuclear Diagnostics, Inc.1994-02-25
PLATO 3000 (K933088)Rosys, Inc.1994-02-25
ADVANCE PREGNANCY TEST MODIFICATION (K934516)Ortho Pharmaceutical Corp.1994-02-24
SAS(TM) DIRECT MONOCLONAL HCG (K935863)Sa Scientific, Inc.1994-02-24
I-STAT TESTS FOR ACID-BASE PARAMETERS (K936081)I-Stat Corp.1994-02-24
CHLORIDE (MF) ASSAY (K934588)Diagnostic Chemicals , Ltd.1994-02-18
QUANTAPHASE II B12/FOLATE (K935286)Bio-Rad1994-02-18
REFRACTOMETRIC, TOTAL PROTEIN (K933218)Pyramid Biological Corp.1994-02-17
TRI-TECH INC. CUSTOM SEXUAL ASSAULT KIT (K922343)Tri-Tech, Inc.1994-02-17
THE BUCK (K933401)Medical Implements, Inc.1994-02-10
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT (K933939)Organon Teknika Corp.1994-02-07
NON INVASIVE VASCULAR PROGRAM (K932852)D. E. Hokanson, Inc.1994-02-04
CIBA CORNING 248 PH/BLOOD GAS ANALYZER (K935830)Ciba Corning Diagnostics Corp.1994-02-03
IL TEST CALCIUM (K931362)Instrumentation Laboratory CO1994-02-01
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT (K932888)Intersect Systems, Inc.1994-01-31
P-AMYLASE CONTROL (K935362)Beckman1994-01-27
EVENT TEST STRIP HCG (K935502)Boehringer Mannheim Italia Spa1994-01-27
IMMULITE PAP (K931701)Diagnostic Products Corp.1994-01-27
MAS LIQUID URINALYSIS CONTROL (K935062)Medical Analysis Systems, Inc.1994-01-27
ASPARTATE AMINOTRANSFERASE (AST) TEST (K935181)Em Diagnostic Systems, Inc.1994-01-27
COBAS (R) CORE T4 EIA (K932605)Roche Diagnostic Systems, Inc.1994-01-24
COBAS(R) CORE FT4 EIA (K932607)Roche Diagnostic Systems, Inc.1994-01-24
REAGENTS FOR ORION 1020, AND RELATED ANALYZERS (K935018)Alko Diagnostic Corp.1994-01-18
CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER (K935547)Alko Diagnostic Corp.1994-01-18
CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR (K925464)Alko Diagnostic Corp.1994-01-13
ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS (K930231)Alko Diagnostic Corp.1994-01-13
ALANINE AMINOTRANSFERASE (ALT) TEST (K935180)Em Diagnostic Systems, Inc.1994-01-13
ALKO FLUIDS PACKS FOR NOVA ANALYZERS (K930199)Alko Diagnostic Corp.1994-01-13
UROPAPER EIKEN 6B (K932368)Tanabe U.S.A., Inc.1994-01-13
REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) (K925385)Alko Diagnostic Corp.1994-01-13
DIRECTDRAW SUPERSERUM-MINI (K935081)International Technidyne Corp.1994-01-11
CREATINE KINASE-MB (CK-MB) REAGENT SET (K935463)Pointe Scientific, Inc.,1994-01-11
IMMULITE PROGESTERONE (K935138)Diagnostic Products Corp.1994-01-11
MODEL 5500 CEAS (K934977)Esa, Inc.1994-01-11
ONE STEP LH TEST (K935134)Tcpi, Inc.1994-01-11
N-ASSAY TIA MICROALBUMIN (K934146)Crestat Diagnostics, Inc.1994-01-11
RELIEF PLUS ONE REAGENT STRIP MODIFICATION (K934892)Diagnostic Solutions, Inc.1994-01-11
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810)Hybritech, Inc.1994-01-11
CHOLESTEROL ENZYMATIC ENDPOINT (K923504)Randox Laboratories, Ltd.1994-01-10
IMMULITE ESTRADIOL (K932926)Diagnostic Products Corp.1994-01-10
ACTIVE ANDROSTANEDIOL GLUCURONIDE (K934751)Diagnostic Systems Laboratories, Inc.1994-01-10
SIGMA ELECTROLYTE REFERENCE REAGENT (K933696)Sigma Chemical Co.1994-01-03
IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM (K935287)Miles, Inc.1994-01-03
860 MEASURMENT SYSTEM (K934907)Ciba Corning Diagnostics Corp.1994-01-03
ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT (K921868)Endocrine Sciences Products1994-01-03
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET (K934923)Unipath , Ltd.1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET (K934922)Unipath , Ltd.1993-12-29
PARA 4 PLUS (K933844)Streck Laboratories, Inc.1993-12-27
EMDS PHOSPHOROUS (PHOS) TEST (K935178)Em Diagnostic Systems, Inc.1993-12-17
SIGMA BUN REAGENT (K933679)Sigma Chemical Co.1993-12-17
EMDS ALBUMIN (ALB) TEST (K935179)Em Diagnostic Systems, Inc.1993-12-17
SIGMA CO2 ALKALINE BUFFER REAGENT (K933691)Sigma Chemical Co.1993-12-17
I-STAT IONIZED CALCIUM TEST (K934642)I-Stat Corp.1993-12-17
CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (K935136)Em Diagnostic Systems, Inc.1993-12-16
TOTAL PROTEIN TEST (TPRO) (K935174)Em Diagnostic Systems, Inc.1993-12-16
IRON TEST (K935176)Em Diagnostic Systems, Inc.1993-12-16
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (K935177)Em Diagnostic Systems, Inc.1993-12-16
LACTATE DEHYDROGENASE (LD) (K935175)Em Diagnostic Systems, Inc.1993-12-16
SIGMA WASH CONCENTRATE SOLUTION (K933703)Sigma Chemical Co.1993-12-10
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (K932766)Diagnostic Chemicals, Ltd. (Usa)1993-12-10
IMMUNLITE INTACT PTH (K934760)Diagnostic Products Corp.1993-12-10
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY (K934562)Ciba Corning Diagnostics Corp.1993-12-10
EMDS MAGNESIUM (MG) TEST (K935183)Em Diagnostic Systems, Inc.1993-12-09
SIGMA CO2 ACID REAGENT (K933692)Sigma Chemical Co.1993-12-09
SPINPRO HDL PRECIPITATING REAGENT (K934961)Merchant House Scientific1993-12-09
EMDS ALKANINE PHOSPHATASE (ALP) TEST (K935182)Em Diagnostic Systems, Inc.1993-12-09
I-STAT CONTROL LEVELS 1,2,3 (K934641)I-Stat Corp.1993-12-09
QUANTIMETRIX BLOOD GLUCOSE CONTROLS (K932623)Quantimetrix Corp.1993-12-09
APEC GLUCOSE ANALYZER (K931196)Apec, Inc.1993-12-07
SPINPRO HDL PRECIPITATING REAGENT (K934801)Merchant House Scientific1993-12-07
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION (K934900)Heraeus Kulzer, Inc.1993-12-07
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION (K934898)Heraeus Kulzer, Inc.1993-12-07
COBAS CORE TSH EIA (K930776)Roche Diagnostic Systems, Inc.1993-12-03
CIBA CORNING ACS FREE T3 IMMUNOASSAY (K932747)Ciba Corning Diagnostics Corp.1993-12-03
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