Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
CORTISOL KIT (K830148)Cambridge Medical Technology1983-02-09
IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS (K823352)American Dade1983-02-07
TANDEM E GCG VISUAL END POINT INNUMOENZ (K830138)Hybritech, Inc.1983-02-07
SIGMA 300 GAS CHROMATROGRAPH (K830147)The Perkin-Elmer Corp.1983-02-07
CALIBRATOR A (K830137)Hi Chem, Inc.1983-02-07
PARAMOUNT THYROXINE ASSAY (K830136)Syva Co.1983-02-07
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ (K823389)Nova Biomedical Corp.1983-02-02
ULTRAZYME PLUS GAMMA-GT, #64959/65032 (K823883)Emd Chemicals, Inc.1983-01-28
COLORIMETERS SERIES ONE 12 (K830101)Innotron of Oregon, Inc.1983-01-28
NEONATAL NTSH RADIOIMMUNOASSAY SYS (K830036)Corning Medical & Scientific1983-01-28
CYCLIC ADENOSINE MONOPHOSHATE BY RADIO (K823504)Immuno Nuclear Corp.1983-01-28
MULTIANALYTE CONTROLS-ALL KINDS (K823929)Fisher Scientific Co., LLC1983-01-28
TOTAL IRON BINDING CAPACITY TEST (K830032)Sclavo, Inc.1983-01-28
URITEST 9, INLAB REAGENT STRIPS URINALY (K822709)Laprol Scientific, Inc.1983-01-28
WAKO INSULIN TEST (K823939)Wako Chemicals USA, Inc.1983-01-28
RAPID CHEM ANALYZER II (K830095)Macomb Chemical Co.1983-01-28
SERUM IRON DIAGNOSTIC TEST KITS (K830104)Sclavo, Inc.1983-01-28
URIC ACID TEST (K823846)Scalavo, Inc.1983-01-24
GENESIS B-HCG (K823753)Armkel, LLC1983-01-24
MONOJECT SAMPLETTE CAPILLARY BLOOD COLL (K823836)Sherwood Medical Co.1983-01-21
DIRECT CREATININE PROCEDURE (K823806)Analytical & Research Chemicals, Inc.1983-01-14
ALKALINE PHOSPHATASE (K823786)Analytical & Research Chemicals, Inc.1983-01-14
CLEANING AGENT (K823750)Shaban Mfg. Co.1983-01-14
ENZYMATIC CHOLESTEROL (COLORIMETRIC (K823784)Analytical & Research Chemicals, Inc.1983-01-14
VARIOUS-ANALYZER CUPS (K823762)Cordis Corp.1983-01-12
SOPHEIA THYROXINE EIA KIT (K823751)Diagnostic Products Corp.1983-01-12
ULTRA CHEM CRESOLPHTHALEIN CALCIUM 65082 (K823756)Em Industries, Inc.1983-01-12
THYROXINE ANALYSIS PRODUCTS/RADIO-FREE (K823264)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-01-12
BUN-UN CENTRIFICHUM 500, #65080/81 (K823300)Emd Chemicals, Inc.1983-01-09
IL 943 FLAME PHOTOMETER (K823480)Instrumentation Laboratory CO1983-01-09
FLOW-PAC LDH REAGENT SET (K823721)Amresco, Inc.1983-01-09
API MDS* (K823785)Analytical Products, Inc.1983-01-09
TRIGLYCERIDE REAGENT (UV) (K823709)Gilford Diagnostics1983-01-07
BIO INTERFERENCE BLANKING MATERIAL (K823687)American Monitor Corp.1983-01-07
NML 6000 CT (K823679)Nuclear Medical Laboratories, Inc.1983-01-07
COBAS REAGENT FOR CREATININE (K823573)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR INORGANIC PHOSPHORUS (K823580)Hoffmann-La Roche, Inc.1983-01-07
PHOSPHORUS REAGENT SET (K823691)Omega Medical Electronics1983-01-07
COBAS REAGENT FOR ALBUMIN (K823574)Hoffmann-La Roche, Inc.1983-01-07
CK-ISOZYME U.V. REAGENT SET (K823550)Gelman Sciences, Inc.1983-01-07
ESTROCEPT STABILIZED ESTROGEN RECEPTOR (K823186)Brl1983-01-07
COBAS STANDARDS FOR ALBUMIN (K823575)Hoffmann-La Roche, Inc.1983-01-07
SPECTROPHOTOMETER (K823720)Macomb Chemical Co.1983-01-07
COBAS STANDARDS FOR CREATININE (K823572)Hoffmann-La Roche, Inc.1983-01-07
COBAS REAGENT FOR TOTAL PROTEIN (K823579)Hoffmann-La Roche, Inc.1983-01-07
BETA FFIRM TEST (K823682)Organon, Inc.1983-01-07
COBAS REAGENT FOR CALCIUM (K823577)Hoffmann-La Roche, Inc.1983-01-07
COBAS STANDARDS FOR CALCIUM-IN-ORGANIC (K823578)Hoffmann-La Roche, Inc.1983-01-07
PREP TYPE A EXTRACTION CARTRIDGE (K823697)E.I. Dupont DE Nemours & Co., Inc.1983-01-05
DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO (K823688)Corning Medical & Scientific1983-01-05
ORTHO BI-LEVEL ASSAYED LIPID PROFILE (K823490)Ortho Diagnostic Systems, Inc.1983-01-05
CHOLESTEROL REAGENT (K823500)Ac Biochemical Laboratories, Inc.1982-12-30
ENZYMATIC GLUCOSE DETERMINATION (K823474)The Dow Chemical Co.1982-12-30
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT (K822944)Travenol Laboratories, S.A.1982-12-30
HUMAN PLASMA CONTROL FOR CEA-ROCHE (K822219)Hoffmann-La Roche, Inc.1982-12-28
ALKPHOR SYSTEM (K823445)California Immuno Diagnostic, Inc.1982-12-28
ULTRA CHEM BAN-UV #65080 & 65081 (K823472)Emd Chemicals, Inc.1982-12-28
CORNING 170 PH/BLOOD GAS ANALYZER (K823570)Corning Medical & Scientific1982-12-28
IMMOPHASE TM HPL RADIOIMMUNOASSAY (K823292)Corning Medical & Scientific1982-12-28
GAMMADAB LH RADIO-KIT #CA-1508 (K823476)Clinical Assays, Inc.1982-12-28
SINGLE VIAL AMYLASE PNP TEST (K823462)Boehringer Mannheim Corp.1982-12-28
ULTRACHEM BUN-UV-GEM SAEC APPLI.#65080& (K823402)Emd Chemicals, Inc.1982-12-26
IN VITRO GAMMACOAT B-HCG RADIO. TEST (K823313)Clinical Assays, Inc.1982-12-22
125-I FSH RADIOIMMUNOASSAY KIT (K823379)Clinetics Corp.1982-12-22
125-I LH RADIOIMMUNOASSAY KIT (K823380)Clinetics Corp.1982-12-22
RIASET PROLACTIN RIA KIT (K823304)Immulok, Inc.1982-12-22
TRIGLYCERIDES REAGENT SET TAG-GK (K823341)Sterling Biochemical, Inc.1982-12-22
TITAN GEL LDH ISOENZYME KIT (K821983)Helena Laboratories1982-12-22
ULTRACHEM ENZYMATIC CHOLESTEROL OXIDASE (K823354)Emd Chemicals, Inc.1982-12-22
URIC ACID REAGENT (K822913)Ac Biochemical Laboratories, Inc.1982-12-20
BIO MAG FREE T4 RADIOIMMUNOASSAY KIT (K823005)Bioclinical Group1982-12-15
DSL 1700 (K822897)Diagnostic Systems Laboratories, Inc.1982-12-15
POSITIVE I.D. SYSTEM (K823266)Abbott Laboratories1982-12-15
FREE & TOTAL ESTRIOL KIT (K823202)Diagnostic Products Corp.1982-12-15
COUNT-10 SYSTEM FOR STAND. URINALYSIS (K823364)V-Tech, Inc.1982-12-15
CARCINO-CEK (K823353)Biologics Intl., Inc.1982-12-14
MONOCLONAL ANTIBODY T4 RADIO-KIT (K823265)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-12-09
KM-KAL L3 (K823044)Kmn Products, Inc.1982-12-09
DSL 1600 (K822898)Diagnostic Systems Laboratories, Inc.1982-12-09
CHOLESTEROL CHOD-PAP TEST (K823302)Boehringer Mannheim Corp.1982-12-09
INNOTRON FLUORIMETER SERIES ONE-10 (K822942)Innotron of Oregon, Inc.1982-12-09
BLOOD GAS EXPER. SYSTEM 8700 (K822778)Exper Corp., Inc.1982-12-03
CAP-RIA 16 (K823240)Capintec, Inc.1982-12-03
LIQUIZYME CALCIUM REAGENT SET (K823219)American Research Products Co.1982-12-03
LIQUIZYME TOTAL PROTEIN REAGENT (K823170)Amresco, Inc.1982-11-29
SINGLE STEP FREE-T4 125I RADIOIMMUNO- (K823144)Corning Medical & Scientific1982-11-29
SBA 300 CLINICAL CHEMISTRY ANALYZER (K823233)Gilford Instrument Laboratories, Inc.1982-11-29
HUMAN PLACENTAL LACTOGEN KIT (K823201)Diagnostic Products Corp.1982-11-29
SPECIAL CONTROL SERUM FOR HDL-CHOLES (K823196)Boehringer Mannheim Corp.1982-11-29
125 I-DEHYDROEPIANDROSTERONE SULFATE (K823200)Wien Laboratories, Inc.1982-11-29
CLINISTAT TDA SERIES (K823112)Miles Laboratories, Inc.1982-11-29
SARTOPHOR SYSTEM FOR ELECTROPHORESIS (K823132)Sartorius Filters, Inc.1982-11-27
URIC ACID STANDARD, 8MG/DL #65078 (K823147)Harleco Diagnostics1982-11-22
MONOJECT SAMPLETTE CAPILLARY SERUM SEP (K823176)Sherwood Medical Co.1982-11-22
CK-UV REAGENT (K823211)Biorent Diagnostic, Inc.1982-11-22
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI (K823213)Boehringer Mannheim Corp.1982-11-22
IMS HEMATOLOGY MIXER (K823124)Innovative Medical Systems, Inc.1982-11-22
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM (K823187)Rai, Inc.1982-11-22
RAICHEM & GT REAGENT (K823090)Reagents Applications, Inc.1982-11-22
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA (K823087)Boehringer Mannheim Corp.1982-11-18
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