FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12073–12096 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 17, 1980
AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM
K792662 · KHQ
Micromedic Systems
Chemistry · 22d
Cleared Jan 17, 1980
COBAS-BIO CENTRIFUGAL ANALYZER
K792671 · JJG
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 16, 1980
CENTRIA LH RIA
K792350 · CEP
Union Carbide Corp.
Chemistry · 58d
Cleared Jan 16, 1980
RIA-QUANT CK-MB TEST KIT
K792504 · JHX
Mallinckrodt Critical Care
Chemistry · 43d
Cleared Jan 16, 1980
CK-MB (CREATINE KINASE-MB) RIA CONTROL
K792524 · JJX
Mallinckrodt Critical Care
Chemistry · 41d
Cleared Jan 16, 1980
NEOCHROME II GLUCOSE, #4044
K792534 · CGA
American Monitor Corp.
Chemistry · 40d
Cleared Jan 16, 1980
TRIIODOTHYRONINE RIA SYSTEM
K792539 · CDP
Radioimmunoassay, Inc.
Chemistry · 37d
Cleared Jan 16, 1980
ELVI MUCAPROTEINS
K792554 · JQN
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
ELVI NON-ESTERIFIED FATTY ACIDS
K792555 · JLH
Volu Sol Medical Industries
Chemistry · 37d
Cleared Jan 16, 1980
IMMUNOSTAT TSH TEST
K792562 · JLW
Meloy Laboratories, Inc.
Chemistry · 35d
Cleared Jan 16, 1980
TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY
K792599 · CDX
Nuclear Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
CHLORIDE REAGENT
K792605 · CHJ
Gilford Diagnostics
Chemistry · 29d
Cleared Jan 16, 1980
T3 UPTAKE (T3U) REAGENTS
K792607 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 29d
Cleared Jan 16, 1980
LEECO P.A.P. QUANT. DIAGNOSTIC KIT
K792652 · JFH
Leeco Diagnostics, Inc.
Chemistry · 26d
Cleared Jan 16, 1980
SENSI-SLIDE
K792657 · JHJ
Hoffmann-La Roche, Inc.
Chemistry · 21d
Cleared Jan 11, 1980
CHEMISTRY ANALYZER REAGENTS
K792482 · CIX
Laboratory Products, Inc.
Chemistry · 53d
Cleared Jan 11, 1980
ACA HIGH DENSITY LIPOPROTEIN CHOLES.
K792509 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jan 11, 1980
SANDARE CHLORIDE PROCEDURE
K792531 · CHJ
Sandare Chemical Co., Inc.
Chemistry · 35d
Cleared Jan 11, 1980
GLUCOSE (HEXOKINASE) REAGENT SET
K792532 · CFR
Macomb Chemical Co.
Chemistry · 35d
Cleared Jan 11, 1980
CREATINE PHOSPHOKINASE (CPK) REAGENT SET
K792533 · JHW
Macomb Chemical Co.
Chemistry · 35d
Cleared Dec 31, 1979
AVL MODEL 940 AUTOMATIC PH/BLOOD GAS
K792230 · CHL
Gauntlet Technology Corp.
Chemistry · 56d
Cleared Dec 31, 1979
SERACON-SRI
K792485 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRI (PROD. # D029
K792486 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d
Cleared Dec 31, 1979
SERACON-SRII
K792487 · JIX
Bhp Diagnostix, Inc.
Chemistry · 28d