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
STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO (K822050)Helena Laboratories1982-08-27
IMMU-COUNT 404 (K822293)Kemble Instruments, Inc.1982-08-24
CO2/CI STANDARDS (K822289)Gilford Diagnostics1982-08-24
C-REACTIVE PROTEIN TEST KIT (K822332)Sclavo, Inc.1982-08-16
TITAN GEL SERUM CONTROL (K821982)Helena Laboratories1982-08-16
IMMO PHASE FSH RADIOIMMUNOASSAY (K822227)Corning Medical & Scientific1982-08-16
ACA URINARY PROTEIN CALIBRATOR (K822232)E.I. Dupont DE Nemours & Co., Inc.1982-08-16
UREA NITROGEN REAGENT SET (MOD. BERTHEL (K822237)Sterling Biochemical, Inc.1982-08-16
GILCHEM Y-GT REAGENT (K822149)Gilford Diagnostics1982-08-12
BI-LEVEL ASSAYED TUMOR MARKER & ANTIN (K821026)Ortho Diagnostic Systems, Inc.1982-08-10
UREA NITROGEN (ENZYMATIC) DETERMINATION (K822154)The Dow Chemical Co.1982-08-05
DADE CHILL TRAY (K822132)American Dade1982-08-05
ACRO PACK (K822121)Gelman Sciences, Inc.1982-08-05
CORNING 101 PRINTER (K822146)Corning Medical & Scientific1982-08-05
IMMUCHEM COVALENT-COAT (K822140)Immuchem Corp.1982-08-05
IGE/THE OPHYLLINE CONTROL SERUM I,II,III (K822133)Kallestad Laboratories, Inc.1982-08-03
DADE DISP. DISPENSING-SPREADING PIPETS (K822078)American Dade1982-07-27
ENZYMATIC CO2 (K822079)American Monitor Corp.1982-07-27
125I QUICK-MB TEST KIT FOR QUANTITATION (K821964)Intl. Immunoassay Laboratories, Inc.1982-07-22
TITAN GEL CPK/LDH ISOENZYME CONTROL (K821981)Helena Laboratories1982-07-22
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT (K821944)Hybritech, Inc.1982-07-22
SGPT-UV REAGENT SET (K821206)Omega Medical Electronics1982-07-22
ZETA-CORT (K821931)Amf Biological and Diagnostics Co.1982-07-22
UREA NITROGEN REAGENT SET (K821212)Omega Medical Electronics1982-07-22
GLUCOSE(ENZYMATIC) REAGENT SET (K821204)Omega Medical Electronics1982-07-22
LDH-UV REAGENT SET (K821201)Omega Medical Electronics1982-07-20
BIO-CAL OPERATION CHECK KIT (K821934)Bio-Analytics Laboratories, Inc.1982-07-20
ALT ENZYME ASSAY KIT (K821946)Travenol Laboratories, S.A.1982-07-20
TRIGLYCERIDE REAGENT SET (K821205)Omega Medical Electronics1982-07-20
BIURET (COLORIMETRIC) TOTAL PROTEIN (K821905)American Monitor Corp.1982-07-20
SGOT-UV REAGENT SET (K821208)Omega Medical Electronics1982-07-20
PREG-PHILE B (K821676)Bio Diagnostic Systems, Inc.1982-07-16
SYVA ADVANCE STANDARDIZATION KIT #2 (K821937)Syva Co.1982-07-16
SYVA ADVANCE STANDARDIZATION KIT #3 (K821938)Syva Co.1982-07-16
ULTRACHEM T-BILI (K821873)Harleco Diagnostics1982-07-14
SGOT REAGENT SET (K821209)Omega Medical Electronics1982-07-14
ULTRAZYME PLUS 2GT (K821871)Harleco Diagnostics1982-07-14
ULTRACHEM T.P. (K821879)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS CK-I (K821883)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS HBD (K821877)Harleco Diagnostics1982-07-14
ULTRA CHEM ALB (K821880)Harleco Diagnostics1982-07-14
ULTRACHEM CREA (K821881)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS GPT (K821882)Harleco Diagnostics1982-07-14
ULTRAZYME PLUS LDH (K821878)Harleco Diagnostics1982-07-14
ULTRACHEM URIC ACID AIDH (K821872)Harleco Diagnostics1982-07-14
SGPT REAGENT SET (K821207)Omega Medical Electronics1982-07-14
CREATININE REAGENT SET (K821199)Omega Medical Electronics1982-07-13
GEMSTAR SYSTEM (K821335)Electro-Nucleonics Laboratories, Inc.1982-07-13
URIC ACID REAGENT SET (K821213)Omega Medical Electronics1982-07-13
RIAGEN B-HCG RIA (K821657)Biogenex Laboratories1982-07-13
ULTRAZYME PLUS ALP (K821870)Harleco Diagnostics1982-07-13
LEVEL II LIPID CONTROL (K821560)Irvine Scientific1982-07-13
REF. ELECTRODE SOL'N.;STANDARD B (K821885)Avl Scientific Corp.1982-07-13
ALBUMIN REAGENT SET (K821193)Omega Medical Electronics1982-07-13
PHILLIPS RADIATION MEASURING INSTRUMENT (K821892)Long Island Scientific1982-07-13
CHOLESTEROL REAGENT SET (K821195)Omega Medical Electronics1982-07-13
HDL PRECIPITANT REAGENT SET (K821203)Omega Medical Electronics1982-07-13
TOTAL BILIRUBIN REAGENT SET (K821197)Omega Medical Electronics1982-07-13
DIRECT GLUCOSE REAGENT SET (K821198)Omega Medical Electronics1982-07-13
ULTRACHEM TRI-ES (K821875)Harleco Diagnostics1982-07-13
ULTRAZYME PLUS GOT (K821876)Harleco Diagnostics1982-07-13
LEVEL I LIPID CONTROL (K821559)Irvine Scientific1982-07-13
ULTRAZYME PLUS AMYL (K821869)Harleco Diagnostics1982-07-13
SERUM TOTAL PROTEIN REAGENT SET (K821210)Omega Medical Electronics1982-07-13
ALKALINE PHOSPHOTASE REAGENT SET (K821200)Omega Medical Electronics1982-07-13
ULTRACHEM PHOS (K821874)Harleco Diagnostics1982-07-13
SERUM CALCIUM REAGENT SET (K821196)Omega Medical Electronics1982-07-13
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. (K820666)Immuno Nuclear Corp.1982-07-13
ULTRACHEM E-GLU (K821868)Harleco Diagnostics1982-07-08
COAT-A-COUNT INSULIN KIT (K821861)Diagnostic Products Corp.1982-07-08
LEVEL I CONTROL SERUM (K821557)Irvine Scientific1982-07-08
ULTRACHEM GLUC-DH (K821867)Harleco Diagnostics1982-07-06
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST (K821738)Miles Laboratories, Inc.1982-07-06
URICACID (K821741)Biodynamics Corp.1982-07-02
BECKMAN URIC ACID STANDARD (K821813)Beckman Instruments, Inc.1982-07-02
PYRIDOXAL-5-PHOSPHATE STRIPES (K821805)Boehringer Mannheim Corp.1982-07-02
MODEL 1020 NA/K ANALYZER (K821822)Thermo Orion1982-07-02
AMERIFLOUR FLUOROMETER (K821807)American Diagnostic Corp.1982-07-02
POSITIVE & NEGATIVE HCG URINE CONTROLS (K821742)Armkel, LLC1982-07-02
BECKMAN URIC ACID REAGENT (K821812)Beckman Instruments, Inc.1982-07-02
NOVA V FLUIDS PACK & EXTERNAL STANDARDS (K821794)Shaban Mfg. Co.1982-07-02
LEVEL II CONTROL SERUM (K821558)Irvine Scientific1982-07-02
ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT (K821553)Amf Biological and Diagnostics Co.1982-06-25
IEC CENTRA 4 CENTRIFUGE (K821756)International Equipment Co.1982-06-25
ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT (K821554)Amf Biological and Diagnostics Co.1982-06-25
ULTRACHEM E-GLU #64976&65040 (K821475)Emd Chemicals, Inc.1982-06-25
GAMMADAB [125] FSH RADIOIMMUNAY KIT (K821611)Clinical Assays, Inc.1982-06-24
AMES/GILFORD OPTIMATE CLIN. CHEM & THER (K821583)Gilford Instrument Laboratories, Inc.1982-06-24
T3 DIAGNOSTIC KIT RIA (K821725)Diagnostic Reagents, Inc.1982-06-24
T3 UPTAKE DIAGNOSTIC KIT (K821722)Diagnostic Reagents, Inc.1982-06-24
AMMONIA REAGENT (K821719)Gilford Diagnostics1982-06-24
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM (K821678)Micromedic Systems1982-06-24
SERIES 10 LIQUID CHROMOTOGRAPH (K821727)The Perkin-Elmer Corp.1982-06-22
SPINCHEM ACID PHOSPHATASE REAGENT (K821674)Smithkline Diagnostics, Inc.1982-06-22
CALCITONIN RIA TEST KIT, DLS 1200 (K821675)Diagnostic Systems Laboratories, Inc.1982-06-22
TITAN GEL HIGH RESOLUTION SERUM PROTEIN (K821688)Helena Laboratories1982-06-22
DOWFLOW ALT-UV DETERMINATION (K821536)The Dow Chemical Co.1982-06-14
(125I) HTSH RADIOIMMUNOASSAY KIT (K821620)Yang Laboratories, Inc.1982-06-14
YSI #24 & 24M GLUCOSE ANALYZERS (K821192)Yellow Springs Instrument Co., Inc.1982-06-14
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS (K821623)Shaban Mfg. Co.1982-06-14
← Previous Next →

Track Clinical Chemistry automatically

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