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
8905–8928 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 13, 1986
CHOLESTEROL PROCEDURE
K861659 · CHH
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
URIC ACID PROCEDURE
K861660 · KNK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TOTAL PROTEIN PROCEDURE
K861663 · CEK
Data Medical Associates, Inc.
Chemistry · 44d
Cleared Jun 13, 1986
TIPSEP-TBG ASSAY
K861735 · CEE
Nuclear Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 13, 1986
LEE-BEAD PROLACTIN (EIA)
K861945 · CFT
Leeco Diagnostics, Inc.
Chemistry · 24d
Cleared Jun 13, 1986
AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT SET
K861967 · JGS
American Research Products Co.
Chemistry · 24d
Cleared Jun 13, 1986
AMRESCO FLOW PAC INORGANIC PHOSPHRUS REAGENT SET
K861968 · CEO
American Research Products Co.
Chemistry · 24d
Cleared Jun 13, 1986
LDP REAGENT CARTRIDGE (NO. 88216)
K862027 · CFJ
Hi Chem, Inc.
Chemistry · 16d
Cleared Jun 11, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K861700 · CHH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 37d
Cleared Jun 11, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA)
K861819 · CGX
Eastman Kodak Company
Chemistry · 30d
Cleared Jun 05, 1986
CREATINE PHROSPHOKINASE (CK) PROCEDURE
K861665 · CGS
Data Medical Associates, Inc.
Chemistry · 36d
Cleared Jun 05, 1986
GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
K861893 · JXL
Hi Chem, Inc.
Chemistry · 20d
Cleared May 29, 1986
TRYPSIN RIA KIT
K861097 · JNO
Microanalytic Research, Inc.
Chemistry · 66d
Cleared May 29, 1986
RAICHEM AMYLASE REAGENT
K861269 · JFJ
Reagents Applications, Inc.
Chemistry · 55d
Cleared May 29, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO)
K861367 · KLS
Eastman Kodak Company
Chemistry · 48d
Cleared May 29, 1986
EMIT COLUMN DIGOXIN ASSAY
K861393 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
EMIT DIGOXIN MOBILE PHASE SOLUTION
K861394 · KXT
Syva Co.
Chemistry · 45d
Cleared May 29, 1986
KINETIC ALKALINE PHOSPHATASE REAGENT KIT
K861638 · CJE
Bio-Analytics Laboratories, Inc.
Chemistry · 29d
Cleared May 29, 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · CIG
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
IRON PROCEDURE
K861652 · JIY
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
AST/GOT PROCEDURE
K861656 · CIT
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
CALCIUM PROCEDURE
K861657 · CIC
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
ALT/GPT PROCEDURE
K861658 · CKA
Data Medical Associates, Inc.
Chemistry · 29d
Cleared May 29, 1986
LACTATE DEHYDROGENASE (LD) PROCEDURE
K861662 · CFJ
Data Medical Associates, Inc.
Chemistry · 29d