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Clinical Chemistry

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

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RecordFirmDate
DIAGNOSTIC PRODUCTS CORP. RIA CONTROL (K800813)Diagnostic Products Corp.1980-04-24
HUMAN THYROID STIM. HORMONE/ARIA II (K800798)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-04-24
SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT (K800770)Sclavo, Inc.1980-04-21
IL MODEL 1303 PH/BLOOD GAS ANALYZER (K800757)Instrumentation Laboratory CO1980-04-21
TESTOK-125 (K800776)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
RENCTK (K800774)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
ALDOCTK-125 (K800775)Sorin Biomedica, Fiat, USA, Inc.1980-04-21
AMERLEX CORTISOL RIA KIT (K800700)Amersham Corp.1980-04-16
CODE QAS.105 PROLACTIN CONTROL SERA (K800708)Amersham Corp.1980-04-16
PROLACTIN RIA KIT (K800740)Amersham Corp.1980-04-16
AMES LAB MANAGEMENT SYSTEM (K800724)Miles Laboratories, Inc.1980-04-16
STANBIO PROSTATIC ACID PHOSPHATASE TEST (K800693)Stanbio Laboratory1980-04-16
MICROMEDIC AUTOMATIC DILUTER (K800606)Micromedic Systems1980-04-16
KODAK EKTACHEM CLINICAL CHEM. SLIDES (K800628)Eastman Kodak Company1980-04-10
BUN REAGENT KIT #88108 (K800616)Hi Chem, Inc.1980-04-10
HYDRAGAMMA 16 (K800601)Innotron of Oregon, Inc.1980-04-10
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D (K800604)Beckman Instruments, Inc.1980-04-10
CENTRIFI CHEM AST/SGOT (K800641)Union Carbide Corp.1980-04-10
NSI CARBON DIOXIDE REAGENT KIT (K800586)Nobel Scientific Industries, Inc.1980-04-04
NSI CALIBRATOR SET (K800588)Nobel Scientific Industries, Inc.1980-04-04
VENTRE/SEP CORTISOL RIA (K800594)Ventrex Laboratories, Inc.1980-04-04
GLUCOSE OXIDASE REAGENT (K800589)Nobel Scientific Industries, Inc.1980-04-04
BUN KIT (K800590)Nobel Scientific Industries, Inc.1980-04-04
TRANSPHOR TM LD LACTATE DEHYDROGENASE (K800568)Corning Medical & Scientific1980-04-04
SERALYZER REFLECTANCE PHOTOMETER/CALIB. (K800524)Miles Laboratories, Inc.1980-04-02
KDA MICRO CHEMICAL ANALYZER (K800572)American Monitor Corp.1980-04-02
LIPASE DETERMINATION (K800550)The Dow Chemical Co.1980-04-02
NSI CHLORIDE REAGENT KIT (K800585)Nobel Scientific Industries, Inc.1980-04-02
NSI CREATININE KIT (K800583)Nobel Scientific Industries, Inc.1980-04-02
NSI SODIUM/POTASSIUM KIT (K800584)Nobel Scientific Industries, Inc.1980-04-02
MICRO ELISA AUTO READER (K800522)Dynatech Laboratories, Inc.1980-03-25
SERTROL PRODUCT # ACS ST 101 (K800559)Analytical Control Systems, Inc.1980-03-25
LIPID CONTROL PRODUCT # ACS LC 101 (K800558)Analytical Control Systems, Inc.1980-03-25
DIFFERENTIAL REFRACTIVE INDEX DETECTOR (K800556)Hewlett-Packard Co.1980-03-25
MAGNESIUM REAGENT (K800327)Alta Diagnostics, Inc.1980-03-25
TRIGLYCERIDES TEST (500NM) (K800551)Reagents Applications, Inc.1980-03-25
CENTRIFICHEM BUN (K800529)Union Carbide Corp.1980-03-20
MONEL 80&90 ULTRAVIOLET-VISIBLE SPEC. (K800523)Varian Assoc., Inc.1980-03-20
LIQUID-STAT LIQUID REAGENT (K800457)Beckman Instruments, Inc.1980-03-20
CORNING TRANSPHOR (K800544)Corning Medical & Scientific1980-03-20
PHOTOVOLT PVA 4M+2 ANALYZER (K800453)Photovolt Corp.1980-03-20
RIA PHASE T4 (K800203)Boehringer Mannheim Corp.1980-03-19
RIA PHASE TBG (K800204)Boehringer Mannheim Corp.1980-03-19
SMAC SYSTEM, T4 METHOD (K800384)Technicon Instruments Corp.1980-03-19
REFRIG. CENTRIFUGE (DRUCKER MODEL) (K800381)Coulter Electronics, Inc.1980-03-19
T3 SOLID PHASE RADIOIMMUNOASSAY KIT (K800436)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-03-19
ANALYTE T4-THYROXINE (K800385)Technicon Instruments Corp.1980-03-19
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. (K800516)E.I. Dupont DE Nemours & Co., Inc.1980-03-19
AUTOSCAN 3 (K792647)Cnr Labs1980-03-17
AMERLEX T-3 RIA KIT (K800374)Amersham Corp.1980-03-12
CK/LD ISOENZYME CONTROL PROD. #ACS CT101 (K800370)Analytical Control Systems, Inc.1980-03-12
BUN REAGENT (K800341)Gilford Diagnostics1980-03-12
BOND ELUT COLUMNS (K800061)Analytichem International, Inc.1980-03-12
SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (K792349)Pfizer, Inc.1980-03-12
CENTRIFICHEM FILTER CALIBRATION SET (K800304)Union Carbide Corp.1980-03-12
NML 5000 AUTO. GAMMA SCINT. COUNTER (K800388)Nuclear Medical Laboratories, Inc.1980-03-12
AMERLEX T-4 RIA KIT (K800300)Amersham Corp.1980-03-05
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV (K800301)Sigma Chemical Co.1980-03-05
DATA MANAGEMENT SYSTEM IL MODEL 775 (K800282)Instrumentation Laboratory CO1980-03-05
SANDARE FAST 340 PHOSPHOROUS PROCEDURE (K800297)Sandare Chemical Co., Inc.1980-03-05
EMIT AUTO CORTISOL ASSAY (K800245)Syva Co.1980-03-03
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. (K800206)E.I. Dupont DE Nemours & Co., Inc.1980-03-03
MICRO MEDICAL DATA SYSTEM II (K800242)Micro/Tel., Inc.1980-03-03
COROMETRICS MEDICAL SYSTEMS 220 PH SYS. (K800271)Transidyne General Corp.1980-02-26
CALIBRATOR NO. 1 & 2, & WASH SOLUTION (K800220)Fisher Scientific Co., LLC1980-02-26
CHLORIDE REAGENT, CUP & CLEANER (K800217)Fisher Scientific Co., LLC1980-02-26
LDC SPECTROMONITOR III (K800289)Laboratory Data Control1980-02-26
MICRO MEDICAL DATA SYSTEM (K800241)Micro/Tel., Inc.1980-02-26
CARBON DIOXIDE CUP REAGENT & REF.RGT. (K800218)Fisher Scientific Co., LLC1980-02-26
SERUM CREATININE; ALK. BUFFER & PICRIC (K800219)Fisher Scientific Co., LLC1980-02-26
SODIUM/POTASSIUM CONDITIONING REAGENT (K800216)Fisher Scientific Co., LLC1980-02-26
LDC CHROMATOGRAPHY ACCESSORY MODULE B (K800046)Laboratory Data Control1980-02-25
RADIOMETER ACID BASE LABORATORY-ABL-3 (K800224)The London Co.1980-02-22
LINEAR ENZYMATIC GLUCOSE SYSTEM (K800200)Simmler, Inc.1980-02-21
LINEAR ENZYMATIC CHOLESTEROL SYSTEM (K800199)Simmler, Inc.1980-02-21
RSL (125 L) PROGESTERONE KIT (K800126)Radioassay Systems Laboratories, Inc.1980-02-13
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS (K800106)Radioimmunoassay, Inc.1980-02-13
VENTRE/SEP T3 UPTAKE RADIOASSAY (K800165)Ventrex Laboratories, Inc.1980-02-13
SYSTEM 203 CHEMISTRY ANALYZER (K800085)Gilford Instrument Laboratories, Inc.1980-02-13
CENTRIFICHEM CK (K800127)Union Carbide Corp.1980-02-13
FOLLICLE STIMULATING HORMONE (K800107)Radioimmunoassay, Inc.1980-02-13
CO2 CONTENT (K800111)American Monitor Corp.1980-02-13
LDH (L-P) REAGENT (K800120)Gilford Diagnostics1980-02-13
CENTRIFICHEM CREATININE (K800129)Union Carbide Corp.1980-02-13
EMC-M-180, T3 UPTAKE - 100 TUBES (K800188)Endocrine-Metabolic Center1980-02-13
ACCUSTROKE PIPET (K800141)Beckman Instruments, Inc.1980-02-13
CENTRIFICHEM URIC ACID (K800130)Union Carbide Corp.1980-02-13
STANBIO DIRECT URIC ACID TEST SET #0770 (K800190)Stanbio Laboratory1980-02-13
DURAZYME GPT/ALT (K800115)American Monitor Corp.1980-02-13
CENTRIFICHEM BUN (K800128)Union Carbide Corp.1980-02-13
CALBIOCHEM-BEHRING RIA-COUNT (K792460)Calbiochem-Behring Corp.1980-02-13
DURAZYME GOT/AST (K800116)American Monitor Corp.1980-02-13
MICROMEDIC PUNCH & ELUTER (K800075)Micromedic Systems1980-02-13
AMES RIALYZE - CHROMATOGRAPHY TUBES (K800169)Miles Laboratories, Inc.1980-02-13
EMC-M-175, THYROXINE - 100 TUBES (K800187)Endocrine-Metabolic Center1980-02-13
AMES RIALYZE - UPTAKE CHROM. TUBES (K800170)Miles Laboratories, Inc.1980-02-13
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE (K800131)Union Carbide Corp.1980-02-11
MICRO ELISA MINI READER (K800057)Dynatech Laboratories, Inc.1980-02-11
PIPET CALIBRATION KIT (K800062)Streck Laboratories, Inc.1980-02-11
GLUCOSE OXIDASE REAGENT KIT (K800070)Fisher Scientific Co., LLC1980-02-05
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