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Clinical Chemistry

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

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RecordFirmDate
T3 UPTAKE KIT (K810857)Immuno Assay Corp.1981-04-08
ACRODISC (K810829)Gelman Sciences, Inc.1981-04-08
SORVALL RT6000 REFRIGERATED TABLETOP (K810833)E.I. Dupont DE Nemours & Co., Inc.1981-04-08
SILVER ANODE (K810550)Nobel Scientific Industries, Inc.1981-04-08
THERMAL PRINTER PAPER (K810549)Nobel Scientific Industries, Inc.1981-04-08
PREFILLED ARTERIAL BLOOD SAMPLING SYRING (K810816)Current Technologies, Inc.1981-04-07
TECHNICON STAR SYSTEM T3 RIA METHOD (K810798)Technicon Instruments Corp.1981-04-07
T4 RIA KIT (K810811)Immuno Assay Corp.1981-04-07
API TURBICITY STANDARD (K810762)Analytical Products, Inc.1981-04-03
PROGESTERONE KIT (K810804)Cambridge Nuclear Corp.1981-04-01
A-GENT UREA NITROGEN (K810794)Abbott Laboratories1981-04-01
SERALYZER SYSTEM (K810639)Miles Laboratories, Inc.1981-03-31
LEECO LH-QUANT DIAGNOSTIC KIT (K810662)Leeco Diagnostics, Inc.1981-03-31
LECITHIN-SPINGOMYELIN STAND. & KITS (K810743)Supelco, Inc.1981-03-31
C-PEPTICE REAGENTS (K810718)Calbiochem-Behring Corp.1981-03-31
LUTENIZING HORMONES (K810754)Pcl-Ria, Inc.1981-03-31
AMERLEX ESTRIOL RIA KIT (K810667)Amersham Corp.1981-03-31
ESTRIOL RADIOIMMUNOASSAY TEST KIT (K810695)Serono Laboratories, Inc.1981-03-31
AQUEOUS TRIOLEIN STANDARDS & KITS (K810742)Supelco, Inc.1981-03-31
LUTEINIZING HORMONE (K810741)Pcl-Ria, Inc.1981-03-31
ENZYMATIC CHOLESTEROL (K810673)Pointe Scientific, Inc.,1981-03-31
AMPULED FLAME PHOTOMETER STANDARDS (K810618)United Diagnostics, Inc.1981-03-31
ENZYMATIC TRIGLYCERIDE (K810680)Pointe Scientific, Inc.,1981-03-31
AST-UV (PLP-ACTIVATED) DETERMINATION (K810727)The Dow Chemical Co.1981-03-31
COAT-A-COUNT T3 UPTAKE KIT (K810717)Diagnostic Products Corp.1981-03-31
CORNING 178 BLOOD GAS ANALYZER (K810724)Corning Medical & Scientific1981-03-31
ISOLATOR SYSTEM (K810664)E.I. Dupont DE Nemours & Co., Inc.1981-03-31
GLUCOSE OXIDASE (K810674)Pointe Scientific, Inc.,1981-03-31
PANTRAK E.K. (K810669)Calbiochem-Behring Corp.1981-03-31
QUALITROL #65057 (K810725)Harleco1981-03-31
LUMINESCENCE PHOTOMETER 100 SERIES (K810736)Sai Technology1981-03-31
LEECO FSH-QUANT DIAGNOSTIC KIT (K810663)Leeco Diagnostics, Inc.1981-03-27
DPM CALCULATOR (K810631)Iso-Data, Inc.1981-03-27
710 FLUOROMETER/DENSITOMETER (K810619)Corning Medical & Scientific1981-03-27
17B ESTRADIOL (K810204)Pantex, Div. Bio-Analysis, Inc.1981-03-27
EMIT-TFG PRISMA THYROXINE CALIBRATORS (K810587)Syva Co.1981-03-24
FACT* HOME PREGNANCY TEST (K810581)Ortho Pharmaceutical Corp.1981-03-17
ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB (K810536)The Perkin-Elmer Corp.1981-03-17
CENTRIFI CHEM SYSTEM 400 ANALYZER (K810596)Union Carbide Corp.1981-03-17
EMIT-TFG PRISMA THYROXINE ASSAY (K810586)Syva Co.1981-03-17
CORNING 925 CHLORIDE METER (K810615)Corning Medical & Scientific1981-03-17
GERMCO TEST R GLUCOSE TEST KIT (K810567)Fermco Biochemics, Inc.1981-03-13
GEMENI QUICK-MB SEPARATION KIT (K810534)Gemini, Inc.1981-03-11
PRE-VAP CAPS (K810394)Sherman Boosalis1981-03-06
DIGITAL DISPENSING PUMP (K810509)Dynatech Corp.1981-03-06
DAC-CEL DIAGNATAL (K810214)Burroughs Wellcome Co.1981-03-06
BECKMAN DU-8 SPECTROPHOTOMETER (K810511)Beckman Instruments, Inc.1981-03-06
SANDARE NITROPRUSSIDE TEST PROCEDURE (K810514)Sandare Chemical Co., Inc.1981-03-04
GAMMA-GT REAGENT SYSTEM (K810434)American Monitor Corp.1981-02-26
CHOLESTEROL REAGENT (K810405)Gilford Diagnostics1981-02-26
HTSH RIABEAD DIAGNOSTIC KIT (K810381)Abbott Laboratories1981-02-26
ESKACHEM PAP REAGENT (K803234)Smithkline Diagnostics, Inc.1981-02-26
UREA NITROGEN, KINETIC (K810087)Bio-Analytics Laboratories, Inc.1981-02-26
MODEL LC-85 UV DETECTOR (K810304)The Perkin-Elmer Corp.1981-02-25
LIQUID SCINTILLATION SPECTROPHOTOMETER (K810345)Beckman Instruments, Inc.1981-02-25
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM (K810302)Bio-Rad1981-02-25
RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (K810351)Endocrine-Metabolic Center1981-02-23
AST (UV) TEST (K810390)Boehringer Mannheim Corp.1981-02-23
ALT (UV) TEST (K810355)Boehringer Mannheim Corp.1981-02-23
BICARBONATE TEST (K810356)Boehringer Mannheim Corp.1981-02-23
ARTERIAL MICROCOLLECTION SET (K810308)American Dade1981-02-19
EUROCHIMA UREA NITROGEN (K810261)Volu Sol Medical Industries1981-02-10
SODIUM & POTASSIUM TEST KIT (K810253)Mallinckrodt Critical Care1981-02-10
DAC-CEL TSH (K810213)Burroughs Wellcome Co.1981-02-10
MODEL AM 722 (K810203)Applied Medical Technologies1981-02-10
T3 RIA KIT (K810211)E. R. Squibb & Sons, Inc.1981-02-10
CODE IM 2050 AMERLEX FREE T4 RIA KIT (K810231)Amersham Corp.1981-02-10
DAC-CEL T3 UPTAKE (K810212)Burroughs Wellcome Co.1981-02-10
MODEL AM 721 ELECTROLYTE ANALYZER (K810135)Abbott Diagnostics1981-02-10
LEECO P.A.P. - QUANT DIAGNOSTIC KIT (K810232)Leeco Diagnostics, Inc.1981-02-10
ENDAB CORTISOL KIT (K810192)Immunotech Corp.1981-02-06
MICROMEDIC SYSTEMS' AUTOPAK (K810186)Micromedic Systems1981-02-04
MICROMEDIC AUTOMATIC COMPUTING CENTER (K803312)Micomedic Systems1981-02-04
STANBIO BILIRUBIN TEST SET (K810055)Stanbio Laboratory1981-02-02
CHOLESTEROL STANDARD (K810092)Anco Medical Reagents & Assoc.1981-02-02
BCA 1000 (K810105)Biodynamics Corp.1981-02-02
CENTRIFICHEM SYSTEM 500 (K810129)Union Carbide Corp.1981-02-02
URIC ACID REAGENT SYSTEM (K810136)American Monitor Corp.1981-02-02
ALK-PHOS BIOPAK GEL (K810144)Bioware Products1981-02-02
LDH-L LIQUID ENZYMATIC, KINETIC KIT (K810083)Bio-Analytics Laboratories, Inc.1981-01-28
URIC ACID (TPTZ) COLORINMETRIC (K810088)Bio-Analytics Laboratories, Inc.1981-01-28
MINIATURE ION SELECTIVE ELECTRODES (K802856)Ionetics, Inc.1981-01-28
IRON KIT (K810085)Bio-Analytics Laboratories, Inc.1981-01-28
IRON & TICB (K810086)Bio-Analytics Laboratories, Inc.1981-01-28
NUCLI-PAP TM-(I125)-PAP RADIOIMMUNOAS- (K802886)Nuclear Diagnostics, Inc.1981-01-28
6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (K810089)Anco Medical Reagents & Assoc.1981-01-26
MAGNESIUM KIT (K810084)Bio-Analytics Laboratories, Inc.1981-01-26
GLUCOSE STANDARD (K810091)Anco Medical Reagents & Assoc.1981-01-26
RESPA-TROL (K810107)Intensive Technology, Inc.1981-01-26
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT (K810082)Bio-Analytics Laboratories, Inc.1981-01-26
CHOLESTEROL REAGENT (K810090)Anco Medical Reagents & Assoc.1981-01-26
AUTOMATIC BIOCHEMICAL ANALYZER (K810063)Acculab1981-01-26
IMMUNOREACTIVE ESTRIOL RIA KIT (K802754)Microanalytic Research, Inc.1981-01-21
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT (K803278)Immuno Nuclear Corp.1981-01-21
CORTI-SHURE (K810033)Nuclear Medical Laboratories, Inc.1981-01-21
CHOLESTEROL REAGENT ENZYMATIC (K803287)Rai, Inc.1981-01-16
PHOTOMETER (K803285)Turner Designs, Inc.1981-01-16
DUPONT 'ACA' CREATINE KINASE VERIFIERS (K803305)E.I. Dupont DE Nemours & Co., Inc.1981-01-16
FOLLICE STIMULATING HORMONE-RADIOIMM. KT (K803279)Immuno Nuclear Corp.1981-01-16
'NO-BOIL' VITAMIN B12 KIT (K810002)Diagnostic Products Corp.1981-01-16
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