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
9865–9888 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 11, 1984
IL 1312, PH BLOOD GAS MANAGER
K842042
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Jul 09, 1984
VARIAN 3300 & 3400 GAS CHROMATOGRAPHS
K841891 · KZQ
Varian Assoc., Inc.
Chemistry · 63d
Cleared Jul 09, 1984
TRIGLYCERIDES-GPO REAGENT
K842029 · CDT
Reagents Applications, Inc.
Chemistry · 52d
Cleared Jul 09, 1984
VENTREZYME PHENYTOIN KIT IMMUNOASSAY
K842161 · DIP
Ventrex Laboratories, Inc.
Chemistry · 40d
Cleared Jul 09, 1984
TBG RIA
K842167 · CEE
Syncor Intl. Corp.
Chemistry · 39d
Cleared Jul 06, 1984
BEHRING ELISA PROCESSOR M
K841043 · JQW
Behring Diagnostics, Inc.
Chemistry · 116d
Cleared Jul 06, 1984
SENTECH'S ULAB 1000 CLINICAL CHEM.
K841575 · CEM
Sen Tech Medical Corp.
Chemistry · 80d
Cleared Jul 06, 1984
KODAK EKTACHEM CONTROL
K841884 · JJY
Eastman Kodak Company
Chemistry · 60d
Cleared Jul 06, 1984
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY
K842134 · JGQ
Somas Medical Industries, Inc.
Chemistry · 37d
Cleared Jul 06, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K842211 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Jun 28, 1984
SKYNDEX ELECTRONIC BODY FAT CALCULA
K841687 · KTZ
Caldwell, Justiss & Co., Inc.
Chemistry · 66d
Cleared Jun 26, 1984
GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
K842079 · CGC
Immuno Nuclear Corp.
Chemistry · 34d
Cleared Jun 26, 1984
WAKO B.G. PRETEST STRIPS
K842207 · CGA
Healthdyne, Inc.
Chemistry · 22d
Cleared Jun 25, 1984
LYRIS MODULAR INFO SYSTEM
K831830 · JQP
Biovation, Inc.
Chemistry · 384d
Cleared Jun 25, 1984
VITAMIN B12 57CO/FOLATE 125I -
K840462 · CDD
Corning Medical & Scientific
Chemistry · 144d
Cleared Jun 25, 1984
T3 UPTAKE
K841927 · KHQ
Syncor Intl. Corp.
Chemistry · 46d
Cleared Jun 25, 1984
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
K841947 · CHP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
TESTOSTERONE DIRECT RADIOIMMUNOASSAY
K841948 · CDZ
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Jun 25, 1984
DUPONT ACA MAGNESIUM CALIBRATOR
K841955 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 42d
Cleared Jun 25, 1984
GASTRIN RIA
K841963 · CGC
Syncor Intl. Corp.
Chemistry · 42d
Cleared Jun 25, 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010 · CEE
Nichols Institute Diagnostics
Chemistry · 39d
Cleared Jun 25, 1984
SIGMA PROCEDURE 47-UV
K842013 · CGS
Sigma Chemical Co.
Chemistry · 39d
Cleared Jun 22, 1984
FLAME PHOTOMETERS
K834226 · JJO
Dr. Bruno Lange GmbH
Chemistry · 199d
Cleared Jun 22, 1984
DIATRON EASYTEST BLOOD GLUCOSE MONI
K840484 · CGA
Medivix, Inc.
Chemistry · 137d