FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11137–11160 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 11, 1982
SGOT REAGENT SET
K820466 · CIQ
Anco Medical Reagents & Assoc.
Chemistry · 17d
Cleared Mar 11, 1982
ENZYMATIC CHOLESTEROL REAGENT SYSTEM
K820473 · CHH
American Monitor Corp.
Chemistry · 20d
Cleared Mar 11, 1982
SGPT REAGENT SET
K820491 · CKD
Anco Medical Reagents & Assoc.
Chemistry · 16d
Cleared Mar 11, 1982
TOTAL LIPID REAGENT SET
K820500 · CFD
Anco Medical Reagents & Assoc.
Chemistry · 16d
Cleared Mar 08, 1982
LD-L TRIS SYSTEM PACK TEST
K820378 · CFJ
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Mar 08, 1982
LIQUIZYME CO2REAGENT SET
K820388 · JFL
American Research Products Co.
Chemistry · 26d
Cleared Mar 08, 1982
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394 · CKA
Technicon Instruments Corp.
Chemistry · 25d
Cleared Mar 08, 1982
LIQUIZYME CHLORIDE REAGENT
K820411 · JFS
American Research Products Co.
Chemistry · 24d
Cleared Mar 08, 1982
3.5 & 5.5 OZ. SODIUM CHLORIDE SOLUTION
K820460 · JOL
Superior Plastic Products Corp.
Chemistry · 17d
Cleared Mar 05, 1982
NO-BOIL VITABIN B12 5760 FOLATE 125I
K813183 · CDD
Corning Medical & Scientific
Chemistry · 109d
Cleared Mar 04, 1982
GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
K813342 · KSK
Gamma Biologicals, Inc.
Chemistry · 99d
Cleared Mar 04, 1982
ESTRADIOL KIT BY RIA
K820329 · CHP
Immuchem Corp.
Chemistry · 24d
Cleared Mar 04, 1982
AALTO LDH ISOENZYME CONTROL SERUM
K820360 · JJT
Aalto Scientific, Ltd.
Chemistry · 23d
Cleared Mar 04, 1982
ORTHO* BI-LEVEL ASSAYED ALCOHOL DILUEN
K820392 · LAS
Ortho Diagnostic Systems, Inc.
Chemistry · 22d
Cleared Mar 02, 1982
AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM
K820397 · LER
American Diagnostic Corp.
Chemistry · 19d
Cleared Feb 24, 1982
AIRMED SMOKE EVACUATION & FILTER
K820091 · CIE
James L. Geraci & Associates, Inc.
Chemistry · 42d
Cleared Feb 23, 1982
EMIT FREELEVEL SYSTEM I
K820224 · JRL
Syva Co.
Chemistry · 27d
Cleared Feb 18, 1982
BI-LEVEL ASSAYED URINE METAL CONTROL
K820255 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Feb 18, 1982
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K820263 · CHH
Eastman Kodak Company
Chemistry · 16d
Cleared Feb 18, 1982
RAICHEM GOT (AST) REAGENT
K820270 · CIT
Reagents Applications, Inc.
Chemistry · 16d
Cleared Feb 18, 1982
4050/4051 ULTRASPEC
K820273 · JJQ
Lkb Instruments, Inc.
Chemistry · 16d
Cleared Feb 12, 1982
ULTRAZYME PLUS GAMMA GT(65055-65056)
K820233 · JQB
Harleco
Chemistry · 15d
Cleared Feb 12, 1982
TPTZ CHLORIDE
K820235 · CHJ
American Monitor Corp.
Chemistry · 15d
Cleared Feb 12, 1982
WAKO CALCIUM C TEST
K820241 · CIC
Wako Chemicals USA, Inc.
Chemistry · 14d