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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
6625–6648 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 11, 1991
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED
K910147 · CGX
Olympus Corp.
Chemistry · 56d
Cleared Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Mar 06, 1991
CRP LIPID REAGENT TEST PACK
K905648 · CHH
Cirrus Diagnostics, Inc.
Chemistry · 79d
Cleared Mar 06, 1991
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
K910343 · CDD
Ciba Corning Diagnostics Corp.
Chemistry · 36d
Cleared Mar 06, 1991
CLINAK(TM) ISE SUBSYSTEM
K910554 · JGS
Baxter Healthcare Corp
Chemistry · 34d
Cleared Mar 05, 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
K905264 · JGS
Nova Biomedical Corp.
Chemistry · 104d
Cleared Mar 04, 1991
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED
K910108 · JIN
Gds Diagnostics
Chemistry · 53d
Cleared Feb 27, 1991
CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED
K910133 · CHJ
Olympus Corp.
Chemistry · 49d
Cleared Feb 27, 1991
ELECTROPHORESIS CONTROL
K910160 · JIT
Seradyn, Inc.
Chemistry · 43d
Cleared Feb 26, 1991
ECLIPSE ICA CHOLESTEROL
K905145 · CHH
Biotope, Inc.
Chemistry · 103d
Cleared Feb 26, 1991
GGT REAGENT
K905618 · JPZ
Amresco, Inc.
Chemistry · 74d
Cleared Feb 26, 1991
COULTER DART AST (GOT) REAGENT
K905771 · CIT
Coulter Electronics, Inc.
Chemistry · 61d
Cleared Feb 26, 1991
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI
K905820 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Feb 26, 1991
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
K910240 · CHH
Crystal Diagnostics, Inc.
Chemistry · 35d
Cleared Feb 26, 1991
BIOCLONE'S ELEGANCE HCG ELISA KIT
K910420 · JHI
Bioclone Australia Pty , Ltd.
Chemistry · 27d
Cleared Feb 22, 1991
CK-MB IMMUNOASSAY CONTROL
K905623 · JJT
Seradyn, Inc.
Chemistry · 70d
Cleared Feb 22, 1991
ECLIPSE ICA TSH
K910256 · JLW
Biotope, Inc.
Chemistry · 31d
Cleared Feb 22, 1991
ECLIPSE ICA ANALYZER
K910302 · JJQ
Biotope, Inc.
Chemistry · 29d
Cleared Feb 21, 1991
PHARMACIA DELFIA NEONATAL HTSH KIT
K905710 · JLW
Pharmacia, Inc.
Chemistry · 62d
Cleared Feb 21, 1991
TOTAL PROTEIN REAGENT SET
K905790 · CEK
Biochemical Trade, Inc.
Chemistry · 56d
Cleared Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
K905477 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 69d
Cleared Feb 13, 1991
CREATININE (RATE) REAGENT SET
K905619 · CGX
Biochemical Trade, Inc.
Chemistry · 61d
Cleared Feb 13, 1991
KINETIC ALKALINE PHOSPHATASE DETERMINATION
K905650 · CJE
Biochemical Trade, Inc.
Chemistry · 57d
Cleared Feb 13, 1991
CLEARBLUE EASY
K905742 · LCX
Unipath , Ltd.
Chemistry · 51d