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
11329–11352 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 01, 1981
GLUCOSE-HK SYSTEM PACK TEST
K812303 · CFR
Boehringer Mannheim Corp.
Chemistry · 14d
Cleared Sep 01, 1981
SANDARE URIC ACID PROCEDURE
K812313 · LFQ
Sandare Chemical Co., Inc.
Chemistry · 15d
Cleared Sep 01, 1981
LIPO-SEP CHOLESTEROL AUDIT SYSTEM
K812318
Isolab, Inc.
Chemistry · 15d
Cleared Sep 01, 1981
B-NEOCEPT
K812334 · JHJ
Organon, Inc.
Chemistry · 14d
Cleared Sep 01, 1981
UREA NITROGEN (BUN)
K812341 · CDQ
Pointe Scientific, Inc.,
Chemistry · 14d
Cleared Sep 01, 1981
VENTREX DATA REDUCTION & QUAL. CONTR. SY
K812357 · JPK
Ventrex Laboratories, Inc.
Chemistry · 12d
Cleared Aug 31, 1981
TRYPIN (125I) RIA KIT
K811805 · JNO
Bd Becton Dickinson Vacutainer...
Chemistry · 68d
Cleared Aug 31, 1981
ENXYMATIC CREATININE TEST
K812095 · JFY
Boehringer Mannheim Corp.
Chemistry · 38d
Cleared Aug 31, 1981
ACR ENZYMATIC GLUCOSE OXIDASE
K812258 · CGA
Harleco
Chemistry · 19d
Cleared Aug 31, 1981
ACCURATE I
K812261 · JHJ
Organon, Inc.
Chemistry · 19d
Cleared Aug 31, 1981
MONOJECT STERILE CORVAC BLOOD TUBE
K812285 · JKA
Sherwood Medical Co.
Chemistry · 18d
Cleared Aug 31, 1981
HUMAN C-PEPTIDE REAGENTS
K812288 · JKD
Immunex Radiochemical Diagnostics
Chemistry · 18d
Cleared Aug 31, 1981
FUN-UV SYSTEM PACK TEST
K812290 · CDQ
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Aug 31, 1981
CENTRICHEM CHOLESTEROL REAGENT & CALIBRA
K812293 · CHH
Baker Diagnostics
Chemistry · 18d
Cleared Aug 31, 1981
GAMMA GLUTAMY TRANSPEPTIDASE
K812296 · JQB
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Aug 31, 1981
LANCER BUN RATE REAGENT KIT
K812308 · CDS
Sherwood Medical Co.
Chemistry · 14d
Cleared Aug 25, 1981
PHOSPHATE BUFFERED SALINE (1X)
K811791 · JCC
Dutchland Laboratories, Inc.
Chemistry · 62d
Cleared Aug 20, 1981
URIC ACID REAGENT SET
K811764 · LFQ
Anco Medical Reagents & Assoc.
Chemistry · 59d
Cleared Aug 20, 1981
CONCEP-7-BHCG
K812156 · JHI
Leeco Diagnostics, Inc.
Chemistry · 22d
Cleared Aug 20, 1981
COAT-A-COUNT T3 RIA KIT
K812246 · CDP
Diagnostic Products Corp.
Chemistry · 9d
Cleared Aug 13, 1981
GLUCOSE OXIDASE RATE REAGENT
K811165 · CGA
Chem-Elec, Inc.
Chemistry · 107d
Cleared Aug 13, 1981
CHLORIDE REAGENT KIT
K811319 · JFS
Chem-Elec, Inc.
Chemistry · 93d
Cleared Aug 13, 1981
ASTRA
K811381 · JFL
Chem-Elec, Inc.
Chemistry · 90d
Cleared Aug 13, 1981
CREATININE RATE REAGENT KIT
K811406 · CGX
Chem-Elec, Inc.
Chemistry · 86d