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
CREATININE, 64972 (K772157)Harleco1977-12-06
J-VAC VACUUM TUBE (K771874)Jelco Laboratories1977-12-02
URINARY VMA - SCREEN TEST KIT (K772151)Eppendorf-Brinkmann, Inc.1977-11-30
SPECTROPHOTOMETER ANALYSIS SYS. (K771807)Varian Assoc., Inc.1977-11-28
ALPHA/CHOL (K772043)Standard Scientific, Inc.1977-11-28
ENZAC URIC ACID 100-TEST KIT (K772082)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-11-28
SPECTROPHOTOMETER - SERIES AA-575 (K772165)Varian Assoc., Inc.1977-11-28
CREATININE URINE APPLI.-#32308 (K772107)Harleco1977-11-28
QUANTROLS HCG (K772086)Organon, Inc.1977-11-23
BETA-HCG RIA (K772039)Monitor Science Corp.1977-11-23
CHLORIDE (K771832)Gamma Enterprises, Inc.1977-11-22
IN VITRO DIAGNOSTIC REAGENT (K772096)Pcl-Ria, Inc.1977-11-22
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS (K771102)The Dow Chemical Co.1977-11-22
LACTATE DEHYDROGENASE (K771836)Gamma Enterprises, Inc.1977-11-22
IN VITRO T3 RIA TEST (K772108)Clinical Assays, Inc.1977-11-17
CENTRIA INSULIN RIA (K771979)Union Carbide Corp.1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP (K772032)Harleco1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL (K772035)Harleco1977-11-17
T3 RIA KIT (K772122)Antibodies, Inc.1977-11-17
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* (K772033)Harleco1977-11-17
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT (K772029)Harleco1977-11-15
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH (K772028)Harleco1977-11-15
IRON SET, ITEM NO. 65008 (K771927)Harleco1977-11-14
THYRODOT-4 ANTISERA LYOPHOLIZED (K772064)Medcom Diagnostics, Inc.1977-11-14
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT (K772030)Harleco1977-11-14
CALCIUM SET, ITEM NO. 65004 (K771928)Harleco1977-11-14
TOTAL PROTEIN SET, ITEM NO. 64010 (K771926)Harleco1977-11-11
SPECTROPHOTOMETER CARY 219 (K772022)Varian Assoc., Inc.1977-11-11
FASTCHEM BUN (K771923)Boehringer Mannheim Corp.1977-11-11
URIC ACID STD. FOR QUANT. URIC ACID (K772025)Worthington Biochemical Corp.1977-11-11
STAC SYSTEM (K771821)Technicon Instruments Corp.1977-11-07
STAC SYSTEM-ADDI. ANALYTES (K771939)Technicon Instruments Corp.1977-11-03
DYNA ZYME II GOT 340 (K771153)J.T. Baker Chemical Co.1977-11-03
DYNAZYME II GPT 340 (K771152)J.T. Baker Chemical Co.1977-11-03
AMIDO BLACK CONCENTRATE (K771720)Sigma Chemical Co.1977-11-03
SERUM IRON (K771838)Gamma Enterprises, Inc.1977-11-03
CREATININE (K771834)Gamma Enterprises, Inc.1977-11-03
CPK COLOR TEST KIT (K771849)Mallinckrodt Critical Care1977-11-03
DIR. QUANT. COLOR. DETERM. SERUM CREAT. (K771856)Stanbio Laboratory1977-11-03
FILTER SAMPLER BLOOD SERUM FILTER (K771985)Clasrock1977-11-02
AMES T-4 STRIP TEST (K772014)Miles Laboratories, Inc.1977-11-02
DHEA TEST SET (K771793)Wien Laboratories, Inc.1977-11-02
ALKALINE PHOSPHATASE (K771829)Gamma Enterprises, Inc.1977-11-02
INORGANIC PHOSPHORUS (K771835)Gamma Enterprises, Inc.1977-11-02
SODIUM (K771839)Gamma Enterprises, Inc.1977-11-02
POTASSIUM (K771837)Gamma Enterprises, Inc.1977-11-02
ACA BILIRUBIN CALIBRATOR (K771798)E.I. Dupont DE Nemours & Co., Inc.1977-10-28
PHOSPHORUS TEST KIT (K771848)Mallinckrodt Critical Care1977-10-28
ACA TRIGLYCERIDE CALIBRATOR (K771797)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
CENTRIFICHEM SYS 400 ANALYZER (K771813)Clinical Diagnostics, Inc.1977-10-25
SERALUTE TSH (RIA) (K771767)Miles Laboratories, Inc.1977-10-25
ALBUMIN (K771828)Gamma Enterprises, Inc.1977-10-25
MULTISTAT III BICARBONATE TEST (K771507)Instrumentation Laboratory CO1977-10-25
TOTAL PROTEIN (K771841)Gamma Enterprises, Inc.1977-10-25
URIC ACID (K771842)Gamma Enterprises, Inc.1977-10-25
ACA GLUTAMYL TRANSFERASE (K771800)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
BLOOD UREA NITROGEN BUN (K771830)Gamma Enterprises, Inc.1977-10-25
9-WAY URINE TEST WITH ASCORBIC (K771755)Miles Laboratories, Inc.1977-10-25
ACA AMMONIA CALIBRATOR (K771804)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
SPECTROPHOTOMETER ANALYSIS SYSTEM (K771637)Varian Assoc., Inc.1977-10-25
ACA IRON CALIBRATOR (K771802)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
ACA CARBON DIOXIDE CALIBRATOR (K771801)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
CALCIUM (K771831)Gamma Enterprises, Inc.1977-10-25
CHOLAR PRODU&T #17010 (K771731)Hi Chem, Inc.1977-10-25
ACA PHOSPHORUS CALIBRATOR (K771803)E.I. Dupont DE Nemours & Co., Inc.1977-10-25
CHEMCODE/CHEMTEK SYSTEM (K771496)Boehringer Mannheim Corp.1977-10-25
17-HYDROXYPROGESTERONE TEST SET (K771729)Wien Laboratories, Inc.1977-10-21
BG II ANALYZER (K771822)Technicon Instruments Corp.1977-10-19
PROCEDURE NO. 555 (K771916)Sigma Chemical Co.1977-10-19
CARDIOZYME CK-CONTROL LEVEL 1 (K771740)Dade, Baxter Travenol Diagnostics, Inc.1977-10-19
ENZYMATIC CHOLESTEROL (K771820)Macomb Chemical Co.1977-10-19
TOTAL BILIRUBIN (K771840)Gamma Enterprises, Inc.1977-10-19
STAT/LYTE ANALYZER (K771592)Technicon Instruments Corp.1977-10-18
ALKALINE PHOSPHATASE TEST (K771695)Sclavo, Inc.1977-10-18
FOLLICLE-STIMULATING HORMONE (K771756)Nichols Institute Diagnostics1977-10-18
GLUCOSE REAGENT FOR GLUC. ANALYZER (K771754)Harleco1977-10-18
I.L. MODEL 643 FLAME PHOTOMETER (K771337)Instrumentation Laboratory CO1977-10-18
CHOLESTEROL (K771833)Gamma Enterprises, Inc.1977-10-18
TEK-CHEK-2 (K771713)Miles Laboratories, Inc.1977-10-18
TSH RIA REAGENT SET (K771234)G.D. Searle and Co.1977-10-18
NEO TSH-RIA KIT (K771378)Nuclear Medical Systems, Inc.1977-10-18
ELECTROPHORESIS POWER SUPPLY TESTER (K771322)Corning Medical & Scientific1977-10-18
CLINICARD CREATININE CHEMISTRY (K771773)Harleco1977-10-14
PTH RIA (K771783)Nichols Institute Diagnostics1977-10-14
EMIT THYROXINE CONTROL (K771657)Syva Co.1977-10-13
MODEL 2/2 ANALYZER (K771245)Eastman Kodak Company1977-10-07
CARBON DIOXIDE ANALYZER (K771610)Corning Medical & Scientific1977-10-07
NOVA 2 IONIZED CALCIUM ANALYZER (K771643)Nova Biomedical Corp.1977-09-28
SPECTROPHOTOMETEO IL MODEL 651 (K771604)Instrumentation Laboratory CO1977-09-22
PROLACTIN RIA DIAG. KIT (K771656)Abbott Laboratories1977-09-22
T4 BY RIA DIAG. KIT (K771414)Biomedical Labs., Inc.1977-09-22
NSULIN RIA KIT 125I (K771628)Bd Becton Dickinson Vacutainer Systems Preanalytic1977-09-20
MINISTAT-S CHEMISTRY ANALYZER (K771591)Biokinetix Corp.1977-09-20
T3 RIA (K771623)Hoffmann-La Roche, Inc.1977-09-20
IMMUNOSPOT NEONATAL T4 TEST (K771606)Meloy Laboratories, Inc.1977-09-15
ALKALINE PHOSPHATASE ISOENZY. SUB. SET (K771620)Pfizer, Inc.1977-09-15
A-GENT TRIGLYCERIDES (K771608)Abbott Laboratories1977-09-15
AVL BLOOD GAS INSTRUMENT MODEL 939 (K771147)Jones Medical Instrument Co.1977-09-15
THYROID STIMULATING HORMONE (K771590)New England Nuclear1977-09-15
CREATINE KINASE ISOENZYME SUBSTRATE SET (K771605)Pfizer Pharmaceuticals1977-09-15
← Previous Next →

Track Clinical Chemistry automatically

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