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
11449–11472 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 09, 1981
VENTRE/SEP
K811423 · CFP
Ventrex Laboratories, Inc.
Chemistry · 19d
Cleared Jun 09, 1981
TECHNICON STAR SYSTEM
K811431 · JLW
Technicon Instruments Corp.
Chemistry · 18d
Cleared Jun 09, 1981
EMIT-AND METHOTREXATE ASSAY
K811459 · LAO
Syva Co.
Chemistry · 14d
Cleared Jun 09, 1981
WAKO URIC ACID B TEST
K811504 · KNK
Wako Chemicals USA, Inc.
Chemistry · 13d
Cleared May 29, 1981
TAN DEM* - IGE KIT
K802913 · DGC
Hybritech, Inc.
Chemistry · 192d
Cleared May 29, 1981
CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT
K810853 · CGS
The Upjohn Co.
Chemistry · 60d
Cleared May 29, 1981
ALPHA-THAL SCREEN TM CONTROL
K810976 · LGL
Isolab, Inc.
Chemistry · 49d
Cleared May 29, 1981
T3 (RIA) KIT
K811213 · CDP
Immuno Assay Corp.
Chemistry · 25d
Cleared May 29, 1981
KALLESTAD ANTISERA TO PHENOBARBITAL
K811367 · DLZ
Kallestad Laboratories, Inc.
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC PROGESTERONE
K811369 · JLS
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC HPL
K811370 · JMF
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
NATAL-TEC ESTRIOL
K811371 · CGI
Armkel, LLC
Chemistry · 15d
Cleared May 29, 1981
AMES SERA-PAK GLUCOSE REAGENT
K811392 · CGA
Miles Laboratories, Inc.
Chemistry · 11d
Cleared May 29, 1981
EARLY PREGNANCY DETECTION
K811398 · JHI
Immuchem Corp.
Chemistry · 11d
Cleared May 27, 1981
GASTRIN RADIOIMMUNOASSAY TEST
K810722 · CGC
Clinical Assays, Inc.
Chemistry · 71d
Cleared May 27, 1981
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
K811194 · JJE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared May 27, 1981
ULTRACHEM GLUC-DH, ITEM NO. 65048
K811202 · LFR
Harleco
Chemistry · 26d
Cleared May 27, 1981
CORNING 965 CARBON DIOXIDE ANALYZER
K811257 · CHS
Corning Medical & Scientific
Chemistry · 22d
Cleared May 27, 1981
BARALYME CO2 ABSORBENT
K811260 · CBL
Allied Healthcare Products, Inc.
Chemistry · 21d
Cleared May 27, 1981
CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
K811273 · CHO
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274 · JFH
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
NOVA 5
K811289 · JGS
Nova Biomedical Corp.
Chemistry · 16d
Cleared May 27, 1981
COAT-A-COUNT T4 RIA KIT
K811315 · CDX
Diagnostic Products Corp.
Chemistry · 16d
Cleared May 21, 1981
INORGANIC PHOSPHORUS REAGENTS
K811222 · CED
Connecticut Diagnostics, Ltd.
Chemistry · 17d