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
11857–11880 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 14, 1980
HIPP BUFFER(NON-BARBITAL), P/N
K801378 · JJN
Gelman Sciences, Inc.
Chemistry · 33d
Cleared Jul 14, 1980
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409 · JHI
Travenol Laboratories, S.A.
Chemistry · 28d
Cleared Jul 08, 1980
AVL #980 ELECTROLYTE ANALYZER
K801011 · JGS
Gauntlet Technology Corp.
Chemistry · 74d
Cleared Jul 08, 1980
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · CFT
Travenol Laboratories, S.A.
Chemistry · 69d
Cleared Jul 08, 1980
SERALYZER BLOOD UREA NITROGEN(BUN)
K801269 · JGZ
Miles Laboratories, Inc.
Chemistry · 41d
Cleared Jul 08, 1980
TEST FOR KETONE IN URINE(ACETOACETIC AC
K801270 · JIN
Miles Laboratories, Inc.
Chemistry · 41d
Cleared Jul 08, 1980
COBAS REAGENT FOR A-AMYLASE
K801295 · JFJ
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jul 08, 1980
COBAS REAGENT FOR TRIGLYCERIDES & COBAS
K801298 · CDT
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jul 08, 1980
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · JIW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 36d
Cleared Jul 08, 1980
UNASSAYED CHEMISTRY SERUM CONTROL(BOVINE
K801335 · JJY
Warner-Lambert Co.
Chemistry · 34d
Cleared Jun 30, 1980
WAKO PHOSPHOLIPIDS TEST
K801076 · CEL
Wako Pure Chemical Industries, Ltd.
Chemistry · 54d
Cleared Jun 30, 1980
EMIT AAII THYROXINE CALIBRATORS
K801287 · JIS
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
EMIT AAII THYROXINE ASSAY
K801288 · KLI
Syva Co.
Chemistry · 31d
Cleared Jun 30, 1980
ALIZARIN SULFONATE, CALCIUM
K801290 · CID
Union Carbide Corp.
Chemistry · 31d
Cleared Jun 30, 1980
COBAS REAGENT FOR CHOLESTEROL
K801296 · CHH
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 30, 1980
COBAS REAGENT FOR GLUCOSE RAPID
K801297 · CFR
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 26, 1980
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER
K801222 · JIX
Simmler, Inc.
Chemistry · 34d
Cleared Jun 26, 1980
COBAS REAGENTS FOR URIC ACID
K801243 · CDO
Roche Analytical Instruments, Inc.
Chemistry · 30d
Cleared Jun 20, 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · KHQ
Abbott Laboratories
Chemistry · 60d
Cleared Jun 20, 1980
COBAS REAGENT FOR AST (SGOT)
K801118 · CIT
Roche Analytical Instruments, Inc.
Chemistry · 39d
Cleared Jun 20, 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226 · CDT
Reagents Applications, Inc.
Chemistry · 29d
Cleared Jun 20, 1980
COBAS REAGENT FOR ALKALINE PHOSPHATASE
K801242 · CJE
Roche Analytical Instruments, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Jun 17, 1980
COBAS REAGENT FOR BUN
K801116 · CDQ
Roche Analytical Instruments, Inc.
Chemistry · 36d