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
10513–10536 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 02, 1983
BETA-QUIK-15 RIA KIT
K831223 · JHI
Pacific Biotech, Inc.
Chemistry · 48d
Cleared Jun 02, 1983
COMPUR EASY TOUCH CHEMISTRY ANALYZER-
K831227 · JJF
Worthington Diagnostic Systems
Chemistry · 48d
Cleared Jun 02, 1983
QST TM SAMPLE PROCESSOR
K831273 · JQW
Syva Co.
Chemistry · 44d
Cleared Jun 02, 1983
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE
K831342 · CDZ
Diagnostic Products Corp.
Chemistry · 38d
Cleared Jun 02, 1983
IGE RADIOIMMUNOASSAY KIT
K831377 · DGC
American Diagnostic Corp.
Chemistry · 36d
Cleared May 27, 1983
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · CJM
Diagnostic Products Corp.
Chemistry · 46d
Cleared May 27, 1983
PREGNA-CERT, SLIDE PREGNANCY TEST
K831180 · JHJ
Diagnostic Specialties
Chemistry · 46d
Cleared May 27, 1983
EMIT QST THEOPHYLLINE ASSAY
K831272 · KLS
Syva Co.
Chemistry · 38d
Cleared May 25, 1983
AMERLEX FREE T-3 RIA KIT
K830980 · CDP
Amersham Corp.
Chemistry · 57d
Cleared May 25, 1983
DIAGNOSTICS PH ELECTRODE CLEANING SOLUT
K831015 · CHL
Fisher Scientific Co., LLC
Chemistry · 56d
Cleared May 25, 1983
SERUM IRON-PTF-600
K831201 · JIY
American Monitor Corp.
Chemistry · 42d
Cleared May 25, 1983
SERUM UIBC-PTF-600 METHOD
K831202 · JMO
American Monitor Corp.
Chemistry · 42d
Cleared May 18, 1983
HOME PREGNANCY TEST KIT HPK #1
K831051 · LCX
Quidel Corp.
Chemistry · 47d
Cleared May 18, 1983
COAT-A-COUNT NEONATAL T4 KIT RIA KIT
K831107 · CDX
Diagnostic Products Corp.
Chemistry · 43d
Cleared May 18, 1983
HOME PREGNANCY TEST KIT
K831108 · LCX
Quidel Corp.
Chemistry · 43d
Cleared May 16, 1983
EZEE FILTER/SEPARATOR
K831081 · JKA
The Kendall Company Div. of Tyco...
Chemistry · 42d
Cleared May 13, 1983
CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK
K830563 · CGR
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 79d
Cleared May 13, 1983
HELENA BIOSTRIP A
K830978 · JMA
Helena Laboratories
Chemistry · 45d
Cleared May 09, 1983
CYTOMEGELISA STAT
K830615 · LFZ
M.A. Bioproducts
Chemistry · 70d
Cleared May 09, 1983
HUMAN INTRACT PARATHYROID HORMONE BY
K830664 · CEW
Immuno Nuclear Corp.
Chemistry · 67d
Cleared May 09, 1983
BUFFER PACK FOR ABL-1 & ABL-2
K831017 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
FLUSH SOLUTION CONCENTRATE
K831020 · CHL
Fisher Scientific Co., LLC
Chemistry · 40d
Cleared May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 40d
Cleared May 09, 1983
PHASE II T3 RADIOIMMUNOASSAY KIT
K831064 · CDP
Medical & Scientific Designs, Inc.
Chemistry · 35d