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
4465–4488 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 06, 1997
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
K970735 · LBS
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Jun 04, 1997
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018 · CEF
Bio-Rad
Chemistry · 306d
Cleared Jun 04, 1997
PARAMAX CHOLESTEROL REAGENT
K964660 · CHH
Dade Intl., Inc.
Chemistry · 196d
Cleared Jun 04, 1997
ACS ESTADIOL-6 II
K970386 · CHP
Chiron Diagnostics Corp.
Chemistry · 121d
Cleared Jun 04, 1997
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
K970905 · CHI
Beckman Instruments, Inc.
Chemistry · 84d
Cleared Jun 04, 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971220 · JKA
Greiner America, Inc.
Chemistry · 63d
Cleared May 29, 1997
DMA TRIGLYCERIDES PROCEDURES
K971113 · CDT
Data Medical Associates, Inc.
Chemistry · 63d
Cleared May 29, 1997
CHOL OR CHOLESTEROL
K971345 · CHH
Carolina Liquid Chemistries Corp.
Chemistry · 49d
Cleared May 29, 1997
CK REAGENT
K971396 · CGS
Carolina Liquid Chemistries Corp.
Chemistry · 44d
Cleared May 27, 1997
IMMULITE PYRILINKS-D
K971312 · JMM
Diagnostic Products Corp.
Chemistry · 48d
Cleared May 27, 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477 · CDQ
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K971485 · CDO
Trace America, Inc.
Chemistry · 34d
Cleared May 27, 1997
QUANTEX ASO-CRP-RF CONTROL
K971777 · JJT
Instrumentation Laboratory CO
Chemistry · 13d
Cleared May 23, 1997
AUTO HDL CHOLESTEROL CALIBRATOR
K970933 · JIS
Pointe Scientific, Inc.,
Chemistry · 71d
Cleared May 23, 1997
SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT,...
K971333 · JIX
Beckman Instruments, Inc.
Chemistry · 43d
Cleared May 22, 1997
DSL ACTIVE T4 EIA
K971269 · KLI
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 22, 1997
DSL ACTIVE T3 EIA
K971270 · CDP
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared May 21, 1997
ROCHE COBAS AMPLICOR ANALYZER
K964506 · JJF
Roche Molecular Systems, Inc.
Chemistry · 194d
Cleared May 21, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · JKR
Nichols Institute Diagnostics
Chemistry · 183d
Cleared May 21, 1997
SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT
K970919 · KNK
Beckman Instruments, Inc.
Chemistry · 70d
Cleared May 21, 1997
ACE HDL-C REAGENT
K971526 · LBS
Schiapparelli Biosystems, Inc.
Chemistry · 23d
Cleared May 16, 1997
DSL ESTRONE-SULFATE RIA
K970915 · CGF
Diagnostic Systems Laboratories, Inc.
Chemistry · 65d
Cleared May 16, 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · CDD
Diagnostic Products Corp.
Chemistry · 46d
Cleared May 16, 1997
SYNCHRON SYSTEMS THYROXINE REAGENT
K971203 · KLI
Beckman Instruments, Inc.
Chemistry · 45d