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Clinical Chemistry

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

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RecordFirmDate
AMYLASE REAGENT (K921057)Genzyme Corp.1992-03-27
SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS (K915814)Sirchie Finger Print Laboratories, Inc.1992-03-27
MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT (K920712)Medix Biotech, Inc.1992-03-27
ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (K920917)Bio Clinic Co.1992-03-26
VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS (K920856)Hycor Biomedical, Inc.1992-03-26
CHEMSTRIP URINE ANALYZER (K921087)Boehringer Mannheim Corp.1992-03-24
MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD (K920335)Heraeus Kulzer, Inc.1992-03-24
DIRECT PREGNANCY TEST (K920716)Tech-Co, Inc.1992-03-24
MP/S SINGLE WAVELENGTH MINI PHOTOMETER (K920914)Artel, Inc.1992-03-23
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (K920576)Eastman Kodak Company1992-03-23
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR (K920505)Eastman Kodak Company1992-03-23
SYNERMED LDHH-L REAGENT KIT (K921025)Synermed, Inc.1992-03-23
CHEM-CHEM MULTI-ANALYTE (MODIFIED) (K920350)Streck Laboratories, Inc.1992-03-23
MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (K920888)Dynatech Laboratories, Inc.1992-03-19
ABBOTT VERTEX ANALYZER (K920559)Abbott Laboratories1992-03-19
PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) (K920345)Medix Biotech, Inc.1992-03-18
DMA LD KINETIC PROCEDURE (K915803)Data Medical Associates, Inc.1992-03-18
IMMUCHEM TSH-MW ELISA (K920442)Icn Biomedicals, Inc.1992-03-18
ENCORE (K915113)Heraeus Kulzer, Inc.1992-03-18
RIATRAC PLUS (K914958)Becton Dickinson Advanced Diagnostics1992-03-18
MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER (K915366)Ciba Corning Diagnostics Corp.1992-03-17
DSL ACTIVE SHBG (DSL 7400) (K915823)Diagnostic Systems Laboratories, Inc.1992-03-17
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3 (K914204)Medical Analysis Systems, Inc.1992-03-17
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE (K914167)Eastman Kodak Company1992-03-17
AMERLITE PROCESSING CENTER (K915680)Eastman Kodak Company1992-03-11
IL TEST(TM) UREA NITROGEN (K914877)Instrumentation Laboratory CO1992-03-11
LH GEN III SELF-TEST/CONCEIVE (K920160)Quidel Corp.1992-03-11
SYN ELISA MICRO ALBUMIN (K920216)Elias U.S.A., Inc.1992-03-11
MILES LIPASE SERA-PAK METHOD (K920337)Heraeus Kulzer, Inc.1992-03-11
IMMULITE HLH (K920411)Cirrus Diagnostics, Inc.1992-03-11
IL TEST DAT CAL/CONTROL SET D/E (K920419)Instrumentation Laboratory CO1992-03-11
TRACE MAGNESIUM - ARSENAZO REAGENT (K920603)Trace America, Inc.1992-03-11
FIRST CHOICE (K912580)Polymer Technology Corp.1992-03-04
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD (K920336)Heraeus Kulzer, Inc.1992-03-04
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT (K920299)Medix Biotech, Inc.1992-03-04
ABBOTT QUICKSTART AMYLASE, #5AXX (K920583)Em Diagnostic Systems, Inc.1992-03-02
AMERLITE MAB FT4 ASSAY (K920247)Eastman Kodak Company1992-03-02
ACTH IRMA KIT II MITSUBISHI YUKA (K915727)Mitsubishi Yuka America, Inc.1992-03-02
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K920504)Medix Biotech, Inc.1992-03-02
SRI TESTOSTERONE ENZYME IMMUNOASSAY (K915164)Serono-Baker Diagnostics, Inc.1992-03-02
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (K914886)Serono-Baker Diagnostics, Inc.1992-03-02
TSH CONTROL (K915325)Polymedco, Inc.1992-03-02
ACID PHOSPHATASE REAGENT SET (K915705)Tech Intl. Co.1992-02-27
AMMONIA REAGENT SET (K915707)Tech Intl. Co.1992-02-26
URIC ACID REAGENT SET (K914158)Tech Intl. Co.1992-02-21
RSP MEGA SAMPLE PROCESSOR (K915492)Tecan U.S., Ltd.1992-02-21
WATERS 717 AUTOSAMPLER (K920136)Millipore Corp.1992-02-19
IMX ESTRADIOL (K920047)Abbott Laboratories1992-02-18
MODEL 795 FLUOROMETER/DENSITOMETER (K915332)Ciba Corning Diagnostics Corp.1992-02-18
ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD. (K920184)Mbo Laboratories, Inc.1992-02-18
LIPASE REAGENT SET (K915706)Tech Intl. Co.1992-02-18
AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 (K914135)Amersham Corp.1992-02-18
AFFINITY PRG (K920230)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-18
MICROPROTEIN-PR (K915380)Sigma Diagnostics, Inc.1992-02-18
IL TEST(TM) AMLYLASE (K913744)Instrumentation Laboratory CO1992-02-18
AFFINITY B12 (K920078)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-14
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT (K920253)Medix Biotech, Inc.1992-02-14
ENZYMUN-TEST TSH (K915195)Boehringer Mannheim Corp.1992-02-14
MILENIA TOTAL T3 (K914467)Diagnostic Products Corp.1992-02-06
N/T PROTEIN CONTROL UY (K914890)Behring Diagnostics, Inc.1992-02-06
DOCUMENT CK ISOENZYMES CONTROL (K915792)Casco Standards1992-02-06
CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (K912027)Enzyme Technology, Inc.1992-01-30
CHOLESTEROL REGEANT SET (K914160)Tech Intl. Co.1992-01-30
MILENIA DATA REDUCTION (K915806)Diagnostic Products Corp.1992-01-30
AMYLASE (COLORIMETRIC) REAGENT SET (K915710)Tech Intl. Co.1992-01-30
CALIBRATOR (K915797)Alko Diagnostic Corp.1992-01-30
BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST (K914885)Beckman Instruments, Inc.1992-01-30
BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT (K915084)Beckman Instruments, Inc.1992-01-28
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM (K914166)Radiometer America, Inc.1992-01-28
DIMENSION AR CLINICAL CHEMISTRY SYSTEM (K915106)Dupont Medical Products1992-01-28
CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT (K915235)Incstar Corp.1992-01-28
CREATINE KINASE-MB (CK-MB) REAGENT SET (K915709)Tech Intl. Co.1992-01-27
NOVA 11 NA/K/LI ANALYZER (K915178)Nova Biomedical Corp.1992-01-27
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT (K915570)Incstar Corp.1992-01-27
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION (K915701)Eastman Kodak Company1992-01-27
MP MINI PHOTOMETER (K914809)Artel, Inc.1992-01-27
SYNERMED AST/GOT REAGENT KIT (K915555)Synermed, Inc.1992-01-27
NOVA 5 NA/K/C1 ALALYZER (K915177)Nova Biomedical Corp.1992-01-27
GLUCOSE REAGENT SET (K914159)Tech Intl. Co.1992-01-27
IL TEST(TM) CALIBRATION SET SP (K914909)Instrumentation Laboratory CO1992-01-22
INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET (K915708)Tech Intl. Co.1992-01-22
STACKING MICROPLATE WASHER (K915284)Denley Instruments, Inc.1992-01-22
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT (K914756)Medix Biotech, Inc.1992-01-15
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (K914429)Diagnostic Systems Laboratories, Inc.1992-01-15
ABBOTT QUICKSTART TIGLYCERIDES REAGENT (K915732)Em Diagnostic Systems, Inc.1992-01-15
HY-PREP SYSTEM (K913809)Hyperion, Inc.1992-01-15
NOVA 4 NA/K/C1/TCO2/LI ANALYZER (K915176)Nova Biomedical Corp.1992-01-15
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 (K914255)Bio-Rad1992-01-09
IL TEST(TM) HDL CHOLESTEROL (K914811)Instrumentation Laboratory CO1992-01-09
DSL INSULIN RIA (DSL 1600) (K914820)Diagnostic Systems Laboratories, Inc.1992-01-09
DMI BLOD GAS ANALYZER/CARTRIDGE (K915087)Diamond Medical, Inc.1992-01-08
VACUTAINER KIT (K914901)Abbott Laboratories1992-01-08
CORVAC BLOOD COLLECTION TUBE (K915213)Sherwood Medical Co.1992-01-08
ORS-1000 (K915427)Mnlase, Inc.1992-01-07
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 (K914463)Em Diagnostic Systems, Inc.1992-01-03
BIO-RAD TOTAL PROTEIN TEST KIT (K913315)Bio-Rad1992-01-02
QUALICHECK 4 (K915399)Radiometer America, Inc.1992-01-02
QUICKSTART UREA NITROGEN (K914903)Em Diagnostic Systems, Inc.1991-12-31
ADVANCE(R) PREGNANCY TEST (K914990)Ortho Pharmaceutical Corp.1991-12-23
ABBOTT QUICKSTART CHOLESTEROL TEST (K913565)Em Diagnostic Systems, Inc.1991-12-18
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