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
11593–11616 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 23, 1981
BICARBONATE TEST
K810356 · KHS
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 23, 1981
AST (UV) TEST
K810390 · CIT
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Feb 19, 1981
MODEL #53110 DISPOSABLE ANOSCOPE
K810227 · FER
Welch Allyn, Inc.
Chemistry · 23d
Cleared Feb 17, 1981
ALPHA-ANTIPLASM ASSAY
K802840 · LGP
American Dade
Chemistry · 97d
Cleared Feb 17, 1981
PROTEOLYTIC ENZYME CONTROL
K803110 · LGP
American Dade
Chemistry · 69d
Cleared Feb 12, 1981
ACRIDINE ORANGE STAIN
K810040 · IDC
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Feb 10, 1981
MODEL AM 721 ELECTROLYTE ANALYZER
K810135 · JGS
Abbott Diagnostics
Chemistry · 20d
Cleared Feb 10, 1981
MODEL AM 722
K810203 · JFP
Applied Medical Technologies
Chemistry · 18d
Cleared Feb 10, 1981
DAC-CEL T3 UPTAKE
K810212 · KHQ
Burroughs Wellcome Co.
Chemistry · 14d
Cleared Feb 10, 1981
DAC-CEL TSH
K810213 · JLW
Burroughs Wellcome Co.
Chemistry · 14d
Cleared Feb 10, 1981
CODE IM 2050 AMERLEX FREE T4 RIA KIT
K810231 · CEC
Amersham Corp.
Chemistry · 14d
Cleared Feb 10, 1981
LEECO P.A.P. - QUANT DIAGNOSTIC KIT
K810232 · JFH
Leeco Diagnostics, Inc.
Chemistry · 14d
Cleared Feb 10, 1981
SODIUM & POTASSIUM TEST KIT
K810253 · JGM
Mallinckrodt Critical Care
Chemistry · 11d
Cleared Feb 10, 1981
EUROCHIMA UREA NITROGEN
K810261 · CDL
Volu Sol Medical Industries
Chemistry · 11d
Cleared Feb 05, 1981
AUTOPHOR 128
K810047 · JBD
Gelman Sciences, Inc.
Chemistry · 24d
Cleared Feb 04, 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186 · CGN
Micromedic Systems
Chemistry · 13d
Cleared Feb 02, 1981
STANBIO BILIRUBIN TEST SET
K810055 · CIG
Stanbio Laboratory
Chemistry · 20d
Cleared Feb 02, 1981
Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S
K810078 · DIF
Hyland Therapeutic Div., Travenol...
Chemistry · 20d
Cleared Feb 02, 1981
CHOLESTEROL STANDARD
K810092 · JIS
Anco Medical Reagents & Assoc.
Chemistry · 20d
Cleared Feb 02, 1981
BCA 1000
K810105 · JJQ
Biodynamics Corp.
Chemistry · 17d
Cleared Feb 02, 1981
CENTRIFICHEM SYSTEM 500
K810129 · JJE
Union Carbide Corp.
Chemistry · 14d
Cleared Feb 02, 1981
URIC ACID REAGENT SYSTEM
K810136 · KNK
American Monitor Corp.
Chemistry · 12d
Cleared Feb 02, 1981
ALK-PHOS BIOPAK GEL
K810144 · CIN
Bioware Products
Chemistry · 12d
Cleared Jan 28, 1981
MINIATURE ION SELECTIVE ELECTRODES
K802856 · JFP
Ionetics, Inc.
Chemistry · 77d