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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12913–12936 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 03, 1977
GLUCOSE REAGENT (HEXOHINASE)
K771311 · CFR
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
BLOOD UREA NITROGEN (BUN) REAGENT
K771312 · CDW
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CHOLESTEROL REAGENT
K771313 · CGO
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
GLUCOSE REAGENT (O-TOLUIDINE)
K771314 · CGE
Mallinckrodt Critical Care
Chemistry · 16d
Cleared Aug 03, 1977
CREATININE ANALYZER 2
K771335 · CGX
Beckman Instruments, Inc.
Chemistry · 16d
Cleared Aug 02, 1977
SERUM GLUTAMIC PYRUVIC TRANSAMINASE
K770991 · CKA
Macomb Chemical Co.
Chemistry · 62d
Cleared Jul 21, 1977
CHROMATOGRAPHY ANALYSIS SYS, MODEL 8500
K770827
Varian Assoc., Inc.
Chemistry · 77d
Cleared Jul 21, 1977
DATA REDUCTION SYSTEM, DP-3000
K770877 · JQP
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Jul 21, 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059 · CGA
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jul 21, 1977
DIAG. CONDUCTA RATE BUN REAG. SET
K771060 · CDS
J.T. Baker Chemical Co.
Chemistry · 38d
Cleared Jul 21, 1977
CHOLESTEROL KIT
K771067 · CHH
Environmental Chemical Specialties
Chemistry · 38d
Cleared Jul 21, 1977
UNIPAK BUN
K771087 · CDW
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK URIC ACID
K771088 · KNK
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK TOTAL BILIRUBIN
K771089 · CIG
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK GLUCOSE
K771091 · CGE
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK TOTAL & DIRECT BILIRUBIN
K771092 · CIG
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK CHOLESTEROL
K771093 · CGO
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
UNIPAK ALBUMIN
K771094 · CIX
Harleco
Chemistry · 35d
Cleared Jul 21, 1977
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
K771101 · GIG
The Dow Chemical Co.
Chemistry · 31d
Cleared Jul 21, 1977
CLINICARD UV AMYLASE CHEMISTRY
K771131 · JFJ
Harleco
Chemistry · 28d
Cleared Jul 21, 1977
CPK-INT TEST
K771154
Hycel, Inc.
Chemistry · 23d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCERIDE CALI. STD.
K771215 · JIT
Union Carbide Corp.
Chemistry · 16d
Cleared Jul 21, 1977
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
K771216 · JIT
Union Carbide Corp.
Chemistry · 16d
Cleared Jul 21, 1977
LAS-R TEST PROGRAM
K771226 · CFN
Hyland Therapeutic Div., Travenol...
Chemistry · 20d