Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
CENTRIFICHEM ALBUMIN (K802436)Union Carbide Corp.1980-10-31
DRUG DETECTION SYSTEM (K802619)Syva Co.1980-10-31
T4-SQUIBB RIA KIT (K802456)E. R. Squibb & Sons, Inc.1980-10-31
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (K801729)Diagnostics Biochem Canada, Inc.1980-10-31
SP 120 SOPHISTICATE (K802251)Vickers America Medical Corp.1980-10-23
UCG-BETA SLIDE (K802435)Armkel, LLC1980-10-23
URIC ACID/ALDH (K802371)Boehringer Mannheim Corp.1980-10-23
DEHYDROEPIANDROSTERONE SULFATE KIT RIA (K802195)Radioassay Systems Laboratories, Inc.1980-10-23
COMBOSTAT - NO-BOIL KIT (K801578)Ria Products, Inc.1980-10-23
SERUM SEPARATOR (K802211)Scientific Specialties, Inc.1980-10-23
ANALYTE T3 UPTAKE (K802246)Technicon Instruments Corp.1980-10-23
TRIGLYCERIDES DETERMINATION (K802256)Coleman Laboratories Corp.1980-10-23
VITAMIN B12 - NO-BOIL KIT (K801579)Ria Products, Inc.1980-10-23
ASTRA PRINTER PAPER #88112-CHLORIDE SILV (K802392)Hi Chem, Inc.1980-10-23
SURETY COLUMN (K802209)Scientific Specialties, Inc.1980-10-23
KLINAR REAGENT PAK, #36010 (K801892)Hi Chem, Inc.1980-10-23
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (K802376)Eastman Kodak Company1980-10-23
CORTISOL125 RADIOIMMUNOASSAY (K802036)Corning Medical & Scientific1980-10-23
UCG-BETA STAT (K802421)Armkel, LLC1980-10-23
IL TOTAL PROTEIN REAGENT (K802310)Instrumentation Laboratory CO1980-10-23
HEPA-SHURE -L (K802120)Nuclear Medical Laboratories, Inc.1980-10-20
KEMTROL SERUM CONTROL-NORMAL (K802108)Helena Laboratories1980-10-10
REAGENTS USED-QUAN. MEASURE OF SERUM (K802154)Panmed, Inc.1980-10-10
GLUCOSE DIAGNOSTIC REAGENT (K801897)Connecticut Diagnostics, Ltd.1980-10-10
8-HYDROXYQUINOLINE, CRESOLPHTHALEIN COM. (K802164)Panmed, Inc.1980-10-10
CHLORIDE COLOR & CHLORIDE SAMPLE DILUENT (K802163)Panmed, Inc.1980-10-10
REAGENTS SERUM CREATINE USING TECHICON (K802156)Panmed, Inc.1980-10-10
AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS (K802159)Panmed, Inc.1980-10-10
AMERICAN MONITOR MAGNESIUM #'S 1036&4021 (K802091)American Monitor Corp.1980-10-10
DELTA TEST TRIGLYCERIDES (K802136)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-10-10
TESTOSTERONE RADIOIMMUNOASSY KIT (K802135)Radioimmunoassay, Inc.1980-10-10
POSTASSIUM BUFFER SOL. & WASH SOLUTION (K802158)Panmed, Inc.1980-10-10
REAGENTS SERUM SODIUM USING THE TECH. (K802155)Panmed, Inc.1980-10-10
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO (K802068)Beckman Instruments, Inc.1980-10-10
PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO (K802343)Intl. Diagnostic, Inc.1980-10-10
KEMTROL SERUM CONTROL ABNORMAL (K802109)Helena Laboratories1980-10-10
BAKER DIAG. ULTRARATE CHLORIDE KIT (K802080)J.T. Baker Chemical Co.1980-10-10
BUN COLOR REAGENT & BUN ACID USED (K802160)Panmed, Inc.1980-10-10
URIC ACID DIAGNOSTIC REAGENT (K801898)Connecticut Diagnostics, Ltd.1980-10-10
CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (K802162)Panmed, Inc.1980-10-10
BCG REAGENT SERUM ALBUMIN W/TECHNICON (K802157)Panmed, Inc.1980-10-10
IN-HOME EARLY PREGNANCY TEST KIT (K802334)Health Diagnostics Corp.1980-10-10
BIURET REAGENT & TOTAL PROTEIN BLANK SOL (K802161)Panmed, Inc.1980-10-10
F/LS MCA APPLICATION SOFTWARE (K801456)Instrumentation Laboratory CO1980-10-03
CONICAL TIPPED CENTRIFUGE TUBE 15M (K802210)Scientific Specialties, Inc.1980-09-26
MODEL 203S CLINICAL CHEMISTRY ANALYZER (K801889)Gilford Instrument Laboratories, Inc.1980-09-26
DUPONT ACALACTIC ACID (LA) TEST (K802064)E.I. Dupont DE Nemours & Co., Inc.1980-09-26
BAKER DIAG. ULTRARATE CO2 REAGENT KIT (K802035)J.T. Baker Chemical Co.1980-09-26
EMBRIA-CK (K801728)Intl. Immunoassay Laboratories, Inc.1980-09-26
MICRO-FLOW SPECTROPHOTOMETER CL-720 (K801957)Shimadzu Precision Instruments, Inc.1980-09-26
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA (K801988)Nordiclab Intl.1980-09-26
MICROLAB M-MICROPROCESSOR DILUTER/DISP (K801913)Hamilton Co.1980-09-26
DATA-ZYME UREA NITROGEN REAGENT SET (K802061)Data Medical Associates, Inc.1980-09-26
UV URIC ACID STANDARDS (K801501)The Dow Chemical Co.1980-09-26
ARIA II 125- I-ESTRIOL SYSTEM (K801735)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-09-16
WAKO HDL CHOLESTEROL TEST (K801834)Wako Pure Chemical Industries, Ltd.1980-09-16
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM (K801896)Beckman Instruments, Inc.1980-09-16
LACTI-QUANT (K801849)Nuclear Medical Laboratories, Inc.1980-09-16
DATA-ZYME AST(GOT) PROCEDURE (K801856)Data Medical Associates, Inc.1980-09-16
WAKO TRIGLYCERIDE-G TEST (K801891)Wako Pure Chemical Industries, Ltd.1980-09-16
GLUCOSE REAGENT(UV-HEXOKINASE) (K801765)Reagents Applications, Inc.1980-09-16
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM (K801749)Beckman Instruments, Inc.1980-09-16
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON (K801882)Nova Biomedical Corp.1980-09-16
SPINAL FLUID CONTROL(HUMAN) (K801854)Environmental Chemical Specialties1980-09-16
DATA-ZYME LAT(GPT) PROCEDURE (K801857)Data Medical Associates, Inc.1980-09-16
T3(125) RADIOIMMUNOASSAY KIT (K801843)Technia Diagnostics , Ltd.1980-09-16
BLOOD GLUCOSE TESTER (K801536)Broomer Research Corp.1980-09-16
CENTRIFICHEM PIPETTOR 1000 (K801851)Union Carbide Corp.1980-09-16
3390A REPORTING INTEGRATOR (K802031)Hewlett-Packard Co.1980-09-16
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (K801795)J.T. Baker Chemical Co.1980-09-16
CORNING 60 VOLT POWER SUPPLY (K801893)Corning Medical & Scientific1980-09-16
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY (K801750)Beckman Instruments, Inc.1980-09-16
ASSURE LEVEL I PROD. #30171 (K801538)Warner-Lambert Co.1980-09-09
HDL CHOLESTEROL TEST KIT (K801726)Mallinckrodt Critical Care1980-09-09
DATA-ZYME UREA NITROGEN, COLORIMETRIC (K801727)Data Medical Associates, Inc.1980-09-09
ASSURE LEVEL II PROD. #30172 (K801539)Warner-Lambert Co.1980-09-09
GAS-CHROMATOGRAPHIC PACKING (K801833)Supelco, Inc.1980-08-27
TESTOSTERONE KIT (K801666)Immuchem Corp.1980-08-27
TSH RIASSAY (K801691)Ria Diagnostics1980-08-27
GLUCOSE (TRINDER) REAGENT (K801600)Gilford Diagnostics1980-08-27
SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) (K801665)Miles Laboratories, Inc.1980-08-20
CORNING 184 BLOOD GAS TONOMETER (K801599)Corning Medical & Scientific1980-08-20
PHOTOMETER LP 3 (K801563)Dr. Bruno Lange GmbH1980-08-20
PHOTOMETER LP 6 (K801562)Dr. Bruno Lange GmbH1980-08-20
BMC RIAFLO SYSTEM (K801481)Boehringer Mannheim Corp.1980-08-20
VISTA 44 GAS CHROMATOGRAPHY ANALYSIS (K801745)Varian Assoc., Inc.1980-08-20
MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (K801772)Radiation Technology, Inc.1980-08-20
SERALYZER GLUCOSE TEST MODULE (K801664)Miles Laboratories, Inc.1980-08-20
ULTRAFREE CALCIUM FILTER (K801500)Millipore Corp.1980-08-20
PHOTOMETER LP 1 (K801564)Dr. Bruno Lange GmbH1980-08-20
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (K801649)Eastman Kodak Company1980-08-20
SERALYZER GLUCOSE REAGENT STRIPS (K801663)Miles Laboratories, Inc.1980-08-20
VENTREX/SEP TSH TEST SET (K801560)Ventrex Laboratories, Inc.1980-08-13
AGA UV PHOTOMETER (K801499)Syva Co.1980-08-13
QUICK CEPT (K801668)Laboratory Diagnostics Co., Inc.1980-08-13
MRI HCG-BETA RIA KIT CAT. #MR-10100 (K801491)Microanalytic Research, Inc.1980-08-13
NSI WASH SOLUTION CONCENTRATE (K800587)Nobel Scientific Industries, Inc.1980-08-08
YSI MODELS 23C & 23CM HDL & TOTAL CHOLES (K801285)Yellow Springs Instrument Co., Inc.1980-07-28
CENTRIFICHEM SYSTEM MANAGER (K801438)Union Carbide Corp.1980-07-28
ESTRIOL RIA KIT FOR USE WITH GAMMAFLO (K801424)Squibb & Sons, Inc.1980-07-21
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