Atlas FDA

Clinical Chemistry

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

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE (K860733)Trace Scientific , Ltd.1986-04-24
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT (K860335)Diagnostic Products Corp.1986-04-24
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 (K861055)Em Diagnostic Systems, Inc.1986-04-24
ALP (ALKALINE PHOSPHATASE) REAGENT (K860715)Trace Scientific , Ltd.1986-04-24
GLUCOSE OXIDASE PROCEDURE (K861204)Data Medical Associates, Inc.1986-04-24
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST (K861221)Em Diagnostic Systems, Inc.1986-04-24
ULTROSPEC K KINETICS SPECTROPHOTOMETER (K861194)Lkb Instruments, Inc.1986-04-24
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID (K860726)Trace Scientific , Ltd.1986-04-21
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04 (K861095)Diagnostic Chemicals, Ltd. (Usa)1986-04-21
VISION SGPT (ALT) (K861002)Abbott Laboratories1986-04-21
VISI-CHECK HLH TEST MONOCLONAL (K860334)Bioclinical Systems, Inc.1986-04-21
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 (K861094)Diagnostic Chemicals, Ltd. (Usa)1986-04-21
IONIZED CALCIUM AND BLOOD PH TESTCARDS (K860639)Ilex Corp.1986-04-21
MUREX (TM), SUDS (TM), HCG ASSAY (K860451)Murex Corp.1986-04-21
BLOOD UREA NITROGEN (BUN) TESTCARD (K860543)Ilex Corp.1986-04-21
MICRO-ELISA HLH TEST KIT MONOCLONAL (K860333)Bioclinical Systems, Inc.1986-04-21
HITACHI 736 (K860748)Boehringer Mannheim Corp.1986-04-17
ES600 IMMUNOASSAY SYSTEM (K860647)Boehringer Mannheim Corp.1986-04-17
ENZYMATIC URIC ACID REAGENT (K860732)Trace Scientific , Ltd.1986-04-16
DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) (K860747)E.I. Dupont DE Nemours & Co., Inc.1986-04-14
STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY (K860422)American Dade1986-04-11
ECHOCLONAL HTSH IRMA (K860288)Bio-Rad1986-04-11
AMRESCO FLOW PAC CREATINE PHOSPHOKINASE REAGENT (K860663)Amresco, Inc.1986-04-11
ENZYMATIC CHOLESTEROL REAGENT (SINGLE VIAL) (K860717)Trace Scientific , Ltd.1986-04-11
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (K860367)Alpkem Corp.1986-04-11
ANSWER PLUS AT HOME PREGNANCY TEST (K860090)Armkel, LLC1986-04-11
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 (K860640)Em Diagnostic Systems, Inc.1986-04-09
FLAME PHOTOMETER STANDARD (K860501)Medical Specialties, Inc.1986-04-07
ACTHK-PR RIA KIT (K860311)Compagnie Oris Industrie, S.A.1986-04-07
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT (K860727)Trace Scientific , Ltd.1986-04-07
EASY-TEST URIC ACID (URIC), #67516/93 (K860916)Em Diagnostic Systems, Inc.1986-04-07
EASY-TEST TOTAL PROTEIN (TP), #67513/93 (K860917)Em Diagnostic Systems, Inc.1986-04-07
GILFORD UNIQUAL NORMAL CONTROL SERUM - ASSAYED (K861068)Ciba Corning Diagnostics Corp.1986-04-07
MARQUEST QC-IV TONOMETER (K855024)Marquest Medical Products, Inc.1986-04-07
ION-SPECIFIC ELECTRODE, CHLORIDE (K860668)Em Diagnostic Systems, Inc.1986-04-07
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI (K851338)Diagnostic Products Corp.1986-04-07
CREATINE KINASE, N-ACETYL-L-CYSTIENE (K860669)Em Diagnostic Systems, Inc.1986-04-07
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II (K860765)Em Diagnostic Systems, Inc.1986-04-07
EMDS ENZYME VERIFIER, LEVELS I & II (K860764)Em Diagnostic Systems, Inc.1986-04-07
L D H-L (LACTIC DEHYDROGENASE) REAGENT (K860728)Trace Scientific , Ltd.1986-04-07
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) (K860724)Trace Scientific , Ltd.1986-04-07
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K860725)Trace Scientific , Ltd.1986-04-07
ALPHA-AMYLASE TEST (K860665)Sclavo, Inc.1986-04-07
AVL MODEL 983 ELECTROLYTE ANALYZER (K861087)Avl Scientific Corp.1986-04-07
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT (K860723)Trace Scientific , Ltd.1986-04-07
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) (K860730)Trace Scientific , Ltd.1986-04-07
LDH-P (LACTIC DEHYDROGENASE) REAGENT (K860729)Trace Scientific , Ltd.1986-04-07
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) (K860731)Trace Scientific , Ltd.1986-04-07
VES-TEC/VES-MATIC (K854223)Marvic Interpharma, Inc.1986-04-04
PRECINORM IM AND PRECIPATH IM (K860970)Boehringer Mannheim Corp.1986-04-03
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED (K860998)Ciba Corning Diagnostics Corp.1986-04-03
A-GENT LIQUID TOTAL BILIRUBIN (K860424)Abbott Laboratories1986-04-03
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED (K861000)Ciba Corning Diagnostics Corp.1986-04-03
A-GENT LIQUID TOTAL PROTEIN (K860426)Abbott Laboratories1986-04-03
A-GENT LIQUID CALCIUM (K860425)Abbott Laboratories1986-04-03
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM (K860799)Technicon Instruments Corp.1986-04-03
SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485)Sterling Diagnostics, Inc.1986-04-03
EASY-TEST AMLASE (AMYL), #67521/93 (K860918)Em Diagnostic Systems, Inc.1986-04-03
URIC ACID REAGNET SET (TRINDER) (K860477)Sterling Diagnostics, Inc.1986-04-03
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET (K860667)Sterling Diagnostics, Inc.1986-04-03
SGOT (AST) REAGENT SET (K860216)Sterling Diagnostics, Inc.1986-04-03
BIOGRAM APO A1/B (K860629)Bio-Rad1986-03-28
SIMULATOR (K854265)Cygnus of South Florida, Inc.1986-03-18
TSH-IRMA COAT-A-COUNT KIT (K860054)Diagnostic Products Corp.1986-03-17
ALDOSTERONE DIRECT RIA KIT (K854876)Biotecx Laboratories, Inc.1986-03-17
SERIES 410 LC PUMP (K860197)The Perkin-Elmer Corp.1986-03-17
TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS (K860690)Catachem, Inc.1986-03-17
GLUCOSE HK-60 ASSAY KIT CAT. #201-39 (K860625)Diagnostic Chemicals, Ltd. (Usa)1986-03-17
BOVINE CHEMISTRY CONTROL I.X AND II.X (K860355)American Dade1986-03-17
CALIBRATION REFERENCE I & II (K855035)Integrated Medical Systems Int'L., Inc.1986-03-17
TOTAL BILIRUBIN REAGENT SET (K860214)Sterling Diagnostics, Inc.1986-03-17
SANDARE BCG ALBUMIN PROCEDURE (K860684)Sandare Chemical Co., Inc.1986-03-17
SUCROSEP LUTEINIZING HORMONE (LH) IRMA (K860308)Boots-Celltech Diagnostics, Inc.1986-03-17
LEECO TESTOSTERONE DIAGNOSTIC KIT (K860003)Leeco Diagnostics, Inc.1986-03-17
A-GENT LIQUID ALBUMIN (K860423)Abbott Laboratories1986-03-17
CHEMISTRY CONTROL N & A (K855036)Integrated Medical Systems Int'L., Inc.1986-03-17
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET (K860348)Sterling Diagnostics, Inc.1986-03-17
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (K855014)Kallestad Laboratories, Inc.1986-03-14
ENZYMATIC ALPHA-AMYLASE REAGENT KIT (K860245)Bio-Analytics Laboratories, Inc.1986-03-14
AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) (K860253)Amersham Corp.1986-03-14
SERUM IRON & IRON BINDING REAGENT SET (K860478)Sterling Diagnostics, Inc.1986-03-14
SERUM LIPASE REAGENT SET (TURBIDIMETRIC) (K860554)Sterling Diagnostics, Inc.1986-03-14
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS (K855091)Sen Tech Medical Corp.1986-03-14
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271 (K860662)Amresco, Inc.1986-03-14
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT (K860661)Amresco, Inc.1986-03-14
AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K860660)Amresco, Inc.1986-03-14
CAT-3 CATECHOLAMINE ASSAY KIT (K855214)Whale Scientific, Inc.1986-03-14
ANDROSTENEDIONE 125I KIT BY RIA (K860559)Immuchem Corp.1986-03-14
INORGANIC PHOSPHORUS REAGENT SET (K860628)Sterling Diagnostics, Inc.1986-03-14
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 (K855079)Em Diagnostic Systems, Inc.1986-03-05
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY (K860490)Medix Biotech, Inc.1986-03-05
ABL330 ACID BASE LABORATORY (K860057)Radiometer America, Inc.1986-03-05
CPK (UV) REAGENT KIT (K855188)Technostics Intl.1986-03-05
ACID PHOSPHATASE REAGENT SET (K860476)Sterling Diagnostics, Inc.1986-03-05
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT (K860542)Hybritech, Inc.1986-03-05
ENCORE PROLACTIN REAGENT (K860221)Hybritech, Inc.1986-03-05
SKD ELECTROCHEMICAL SYSTEM (ECS) (K854723)Smithkline Diagnostics, Inc.1986-03-05
DELFIA TM HLH KIT (K855173)Lkb Instruments, Inc.1986-02-28
LACTATE DEHYDROGENASE (LDH) REAGENT SET (K860349)Sterling Diagnostics, Inc.1986-02-28
AMYLASE REAGENT SET (MODIFIED CARAWAY) (K860530)Sterling Diagnostics, Inc.1986-02-28
← Previous Next →

Track Clinical Chemistry automatically

Every clearance here is in the API, with alerts when new ones post.