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
11641–11664 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 16, 1981
AUTOMATED ELECTROPHORESIS SYSTEM
K803281 · JJN
Helena Laboratories
Chemistry · 18d
Cleared Jan 16, 1981
PHOTOMETER
K803285 · JJQ
Turner Designs, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
CHOLESTEROL REAGENT ENZYMATIC
K803287 · CHH
Rai, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
K803296 · KWW
Immunotech Corp.
Chemistry · 17d
Cleared Jan 16, 1981
LUQUIZYME TRIGLYCERIDE REAGENT SET
K803297 · CDT
Amresco, Inc.
Chemistry · 17d
Cleared Jan 16, 1981
CREATINE KINASE REAGENT
K803301 · CGS
Gilford Diagnostics
Chemistry · 17d
Cleared Jan 16, 1981
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305 · JJT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 17d
Cleared Jan 16, 1981
'NO-BOIL' DUALCOUNT KIT
K810001 · CGN
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 16, 1981
'NO-BOIL' VITAMIN B12 KIT
K810002 · CDD
Diagnostic Products Corp.
Chemistry · 10d
Cleared Jan 15, 1981
T3 RIABEAD DIAGNOSTIC KIT
K803261 · CDP
Abbott Laboratories
Chemistry · 22d
Cleared Jan 09, 1981
BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.
K802451 · JHQ
Syn-Kit, Inc.
Chemistry · 93d
Cleared Jan 09, 1981
PARAGON ELECTRO. CREATINE KINASE TEST KI
K802826 · JHX
Beckman Instruments, Inc.
Chemistry · 60d
Cleared Jan 09, 1981
TRIGLYCERIDES (UV)-2 REAGENTS
K803091 · CDT
Reagents Applications, Inc.
Chemistry · 32d
Cleared Jan 09, 1981
TRI-LEVEL RADIOASSAY CONTROL SERA
K803098 · JJY
American Diagnostic Corp.
Chemistry · 32d
Cleared Jan 09, 1981
PARALLEL CHEMICAL ANALYZER
K803135 · JJE
American Monitor Corp.
Chemistry · 28d
Cleared Jan 09, 1981
CARDIO ZYME PLUS CK-MB #65045
K803168 · JHW
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
CARDIOZYME PLUS CK-TOTAL #65046
K803169 · JHS
Harleco
Chemistry · 25d
Cleared Jan 09, 1981
1-125 LABELED TRIIODOTHYRONINE(T3)
K803180 · CDP
Pcl-Ria, Inc.
Chemistry · 24d
Cleared Jan 09, 1981
CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT
K803216 · CIT
Union Carbide Corp.
Chemistry · 22d
Cleared Jan 09, 1981
CORNING 760 FLUOROMETER/DENSITOMETER
K803240 · JQT
Transidyne General Corp.
Chemistry · 17d
Cleared Jan 09, 1981
LIQUID-STAT REAGENT FOR ASSAY OF CHOLES.
K803254 · CHH
Beckman Instruments, Inc.
Chemistry · 17d
Cleared Jan 02, 1981
CORTISOL 125-I RADIOIMMUNOASSAY KIT
K802969 · CGR
Ria Products, Inc.
Chemistry · 42d
Cleared Jan 02, 1981
LEECO TESTO-QUANT DIAGNOSTIC KIT
K803001 · CDZ
Leeco Diagnostics, Inc.
Chemistry · 38d
Cleared Jan 02, 1981
CHLORIDE/TCO2 ANALYZER REAGENTS
K803013 · CHJ
Laboratory Products, Inc.
Chemistry · 35d