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
8713–8736 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 26, 1986
ENZLIPASE, ENZYMATIC LIPASE KIT
K862312 · CHI
Nuclear Diagnostics, Inc.
Chemistry · 100d
Cleared Sep 26, 1986
ALKALINE PHOSPHATASE TEST
K862498 · CJE
King Diagnostics, Inc.
Chemistry · 87d
Cleared Sep 26, 1986
BILIRUBIN TOTAL DIRECT
K863057 · CIG
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
CALCIOMETER
K863059 · CIA
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
TRIGLYCERIDES-E
K863075 · CDT
J. D. Assoc.
Chemistry · 45d
Cleared Sep 26, 1986
ACE II (TRI-LEVEL)
K863095 · JIX
Medical Analysis Systems, Inc.
Chemistry · 44d
Cleared Sep 26, 1986
URIC ACID PROCEDURE
K863251 · KNK
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K863254 · CDT
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
CALCIUM PROCEDURE
K863256 · CIC
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
AST/GOT PROCEDURE
K863257 · CIT
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
GLUCOSE HK PROCEDURE
K863259 · CFR
Data Medical Associates, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
DEMAND TOTAL PROTEIN
K863301 · CEK
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Sep 26, 1986
DELFIA(TM) CORTISOL KIT
K863422 · JFT
Lkb Instruments, Inc.
Chemistry · 22d
Cleared Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
K863477 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Sep 26, 1986
RAICHEM(TM) CHLORIDE REAGENT
K863620 · CHJ
Reagents Applications, Inc.
Chemistry · 10d
Cleared Sep 25, 1986
RSL (125I) ALDOSTERONE KIT
K862204 · CJM
Radioassay Systems Laboratories, Inc.
Chemistry · 107d
Cleared Sep 25, 1986
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT
K862336 · CGR
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 97d
Cleared Sep 25, 1986
METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM
K862955 · KLS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 51d
Cleared Sep 25, 1986
FREE T3 RADIOIMMUNOASSAY KIT
K862968 · KHQ
Bioclinical Group
Chemistry · 50d
Cleared Sep 25, 1986
CHOLESTEROL-E (TOTAL)
K863062 · CHH
J. D. Assoc.
Chemistry · 44d
Cleared Sep 25, 1986
HDL CHOLESTEROL-E
K863065
J. D. Assoc.
Chemistry · 44d
Cleared Sep 25, 1986
ABBOTT SPECTRUM PHOSPHORUS REAGENT
K863088 · CEO
Abbott Laboratories
Chemistry · 43d
Cleared Sep 25, 1986
HPL RIA KIT
K863188 · JMX
Biotecx Laboratories, Inc.
Chemistry · 37d
Cleared Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
K863545 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 13d