Atlas FDA

Clinical Chemistry

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

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RecordFirmDate
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP (K864677)Serono Diagnostics, Inc.1987-01-07
CANWEST OVU-BLUE (K862055)Canwest Medictex, Inc.1987-01-06
RAICHEM(TM) AMMONIA REAGENT (K864706)Reagents Applications, Inc.1987-01-05
ABBOTT SPECTRUM GLUCOSE REAGENT (K864224)Abbott Laboratories1987-01-05
TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY (K864945)Hybritech, Inc.1987-01-05
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 (K864715)Em Diagnostic Systems, Inc.1986-12-31
CHLORIDE REAGENT (K864713)Sigma Diagnostics, Inc.1986-12-31
ALANINE AMINO TRANSFERASE ALT/SGPT (K864906)Tech-Co, Inc.1986-12-31
QKO (TM) AMYLASE B-HA (K864303)Wako Chemicals USA, Inc.1986-12-31
MAGNESIOMETER (K863069)J. D. Assoc.1986-12-31
AP1 COLORIMETER (K864634)Awareness Technology, Inc.1986-12-31
SYNCHRON CX3 (K864236)Beckman Instruments, Inc.1986-12-31
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT (K864939)Beckman Instruments, Inc.1986-12-31
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE (K863841)Hybritech, Inc.1986-12-22
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT (K864133)Diagnostic Systems Laboratories, Inc.1986-12-18
ELECTROPHORESIS DATA CENTER (EDC) (K860645)Helena Laboratories1986-12-17
UBI MAGIWEL(TM) TSH QUANTITATIVE (K864079)United Biotech, Inc.1986-12-16
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE (K863832)Pointe Scientific, Inc.,1986-12-16
DSL-4800 ACTIVE TM TSH EIA SYSTEM (K864134)Diagnostic Systems Laboratories, Inc.1986-12-16
WAKO(TM) GOT II - HA (K864302)Wako Chemicals USA, Inc.1986-12-16
IQ T4 IMMUNOASSAY (K864560)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE (K864075)United Biotech, Inc.1986-12-16
IQ URIC ACID TEST (K864341)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
IQ TRIGLYCERIDES (K864268)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY (K864132)Ciba Corning Diagnostics Corp.1986-12-16
WAKO GPT II - HA (K864335)Wako Chemicals USA, Inc.1986-12-16
TDX(R) II ANALYZER (K864319)Abbott Laboratories1986-12-16
VISION(TM) AMYLASE (K864435)Abbott Laboratories1986-12-16
VIS-CUBE HCG (EIA) (K863933)Leeco Diagnostics, Inc.1986-12-15
CREATINKINETIC (K863079)J. D. Assoc.1986-12-12
LDH S.C.E. (K863068)J. D. Assoc.1986-12-10
MODIFIED SODIUM ELECTRODE (K863907)Ionetics, Inc.1986-12-10
ALT S.C.E. (GPT) (K863053)J. D. Assoc.1986-12-10
PROTEINMETER (K863112)J. D. Assoc.1986-12-10
EXACTECH(TM) (K863468)Travenol Laboratories, S.A.1986-12-08
TRACKER SYSTEM (K860948)Boehringer Mannheim Corp.1986-12-08
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST (K864231)U. S. Diagnostics, Inc.1986-12-04
REFLOTRON(R) ALT (GPT) (K864082)Boehringer Mannheim Corp.1986-12-04
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST (K864081)U. S. Diagnostics, Inc.1986-12-04
TRANSFERMETER (K863066)J. D. Assoc.1986-12-04
URINE DIAGNOSTIC REAGENT STRIPS (K862806)Amatech International, Inc.1986-12-04
MED-PEN/MED-POINT (K853733)Garid, Inc.1986-12-04
TERUMO SENSIBEAD EIA FSH KIT (K863928)Terumo Medical Corp.1986-12-04
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST (K863980)U. S. Diagnostics, Inc.1986-12-04
MICRO-READER (K864060)Hyperion, Inc.1986-11-28
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM (K864230)E.I. Dupont DE Nemours & Co., Inc.1986-11-28
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 (K863963)Em Diagnostic Systems, Inc.1986-11-28
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 (K863962)Em Diagnostic Systems, Inc.1986-11-28
LUTEINIZING HORMONE (LH-IRMA) RIA KIT (K864144)Immuchem Corp.1986-11-24
UREA NITROGEN(BUN) (K863925)Tech-Co, Inc.1986-11-24
AMR RESEARCH TONOMETER (K862958)Associated Medical Representatives1986-11-24
GLUCOMETER-E (K863102)J. D. Assoc.1986-11-24
CHOLESTEROL (K863927)Tech-Co, Inc.1986-11-24
URIC ACID (K863924)Tech-Co, Inc.1986-11-24
LIQUI-SERA COMBO LIGAND/TDM CONTROLS (K863849)Biodiagnostic Intl1986-11-24
PROGESTERONE SYSTEM BY EIA (K864156)Intl. Bioclinical, Inc.1986-11-24
TRIGLYCERIDES (K863923)Tech-Co, Inc.1986-11-24
FERROFAST (K863109)J. D. Assoc.1986-11-24
IQ UREA NITROGEN (K863901)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-11-24
VISION (TM) GGTP (K864208)Abbott Laboratories1986-11-24
MULTI-ANALYTE LIN-TROL (K863751)Sigma Diagnostics, Inc.1986-11-24
UREA NITROGEN TEST (K863889)U. S. Diagnostics, Inc.1986-11-24
BILIRUBIN TOTAL (K863056)J. D. Assoc.1986-11-24
BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD. (K863880)D.R.G. Scientific Industries1986-11-24
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM (K863859)Hybritech, Inc.1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN (K863860)Hybritech, Inc.1986-11-21
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA (K863861)Hybritech, Inc.1986-11-21
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 (K863719)Technicon Instruments Corp.1986-11-13
LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (K863874)Electro-Nucleonics Laboratories, Inc.1986-11-13
TERUMO SENSIBEAD(TM) EIA HLH KIT (K863929)Terumo Medical Corp.1986-11-13
UBI MAGIWEL(TM) FSH QUANTITATIVE (K864080)United Biotech, Inc.1986-11-13
IMMUNO-CEPT D (BETA-MONOCLONAL) (K863741)Immunostics Co., Inc.1986-11-13
A-GENT(TM) LIQUID GLUCOSE TRINDER (K863948)Abbott Laboratories1986-11-13
GLUCOSE OXIDASE (K863926)Tech-Co, Inc.1986-11-13
VISION (TM) CALCIUM (K863670)Abbott Laboratories1986-11-13
ERYTHOCYTE CREATINE (K852767)Panmed, Inc.1986-11-13
UNIDEX GLUCOSE TEST STRIP (K862984)Unidex, Inc.1986-11-05
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 (K863738)Em Diagnostic Systems, Inc.1986-11-05
MONO ACU-SLIDE TEST (K861211)Cal-Tech Diagnostics, Inc.1986-11-05
SMI MULTIPETTOR(TM) (K863887)American Dade1986-11-05
VMAX KINETIC MICROPLATE READER (K863802)Molecular Devices Corp.1986-11-05
LYTENING 2 (K863521)Amdev, Inc.1986-11-05
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM (K863840)E.I. Dupont DE Nemours & Co., Inc.1986-11-05
HCG CONTROL KIT (K863744)Monoclonal Antibodies, Inc.1986-11-05
URIC ACID TEST (K864119)U. S. Diagnostics, Inc.1986-10-29
SERACON CT REFERENCE (K863648)Bhp Diagnostix, Inc.1986-10-29
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 (K863660)Em Diagnostic Systems, Inc.1986-10-29
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 (K863718)Em Diagnostic Systems, Inc.1986-10-29
IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1 (K861883)Orion Corp.1986-10-29
IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B (K861882)Orion Corp.1986-10-29
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (K863478)Em Diagnostic Systems, Inc.1986-10-29
DIRECT BILIRUBIN PROCEDURE (K863265)Data Medical Associates, Inc.1986-10-24
BLOOD SPECIMEN COLLECTION DEVICES (K863491)Medelec Intl. Corp.1986-10-24
OCEAN SCIENTIFIC VACUTEST (K863976)Ocean Scientific, Inc.1986-10-24
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) (K863617)Hi Chem, Inc.1986-10-24
ULTRAWASH I (K863623)Dynatech Laboratories, Inc.1986-10-21
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (K863502)Reagent Laboratory, Inc.1986-10-21
ULTRAWASH II (K863624)Dynatech Laboratories, Inc.1986-10-21
IQ IMMUNOCHEMISTRY SYSTEM (K863531)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-20
TECHNICON RA-XT SYSTEM WITH ANALYTES (K862561)Technicon Instruments Corp.1986-10-20
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