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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12457–12480 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 20, 1978
CHEMSTRIP CONTROL
K781691 · JJW
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Dec 20, 1978
WASHER SYSTEM, MICROELISA
K781802 · JTC
Metrix Teknika, Inc.
Chemistry · 58d
Cleared Dec 20, 1978
SERUM, CREATININE DETERMINATIONS
K781884 · CGX
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
SERUM, BLOOD UREA NITIOGEN
K781885 · CDW
Fisher Scientific Co., LLC
Chemistry · 43d
Cleared Dec 20, 1978
CONTROL, PROTEIN ELECTROPHORESIS
K781893 · JJY
Sigma Chemical Co.
Chemistry · 42d
Cleared Dec 20, 1978
CLEARING SOLUTION #ECA01976
K781898 · JQK
Electrophoresis Corp. of America
Chemistry · 37d
Cleared Dec 20, 1978
UREA NITROGEN TEST
K781899 · CDL
Wako Intl., Inc.
Chemistry · 37d
Cleared Dec 20, 1978
ANALYZER, AUTOMED CENTRIFUGAL
K781900 · JJG
Autogenic Systems
Chemistry · 37d
Cleared Dec 04, 1978
PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS
K781000 · CEO
Abbott Laboratories
Chemistry · 172d
Cleared Dec 04, 1978
ELISA SYSTME
K781269 · JJQ
Gilford Instrument Laboratories, Inc.
Chemistry · 133d
Cleared Dec 04, 1978
DIRECT ESTRIOL RIA KIT
K781546 · CGI
Immunalysis Corporation
Chemistry · 82d
Cleared Dec 04, 1978
CHANGE IN STERILIZATION PROCEDURE
K781727 · GOY
Absorbent Cotton Co., Inc.
Chemistry · 54d
Cleared Dec 04, 1978
SERACON-SRI
K781757 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
SERACON-SRII
K781758 · JIX
Bhp Diagnostix, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
IRON 59 KIT
K781769 · JJA
Ria Products, Inc.
Chemistry · 49d
Cleared Dec 04, 1978
BLOOD SUGAR
K781783 · LFR
Gilford Diagnostics
Chemistry · 46d
Cleared Dec 04, 1978
COMPUTER, 3500, GILFORD SYSTEM
K781828 · KLI
Syva Co.
Chemistry · 35d
Cleared Dec 04, 1978
CHOLESTEROL STANDARDS
K781853 · JIS
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Dec 04, 1978
REAGENT SYSTEM, NO 46-OV FOR CPK
K781859 · CGS
Sigma Chemical Co.
Chemistry · 28d
Cleared Dec 04, 1978
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · JBQ
Ortho Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865 · JIY
Stanbio Laboratory
Chemistry · 28d
Cleared Dec 04, 1978
DILUTER, LSA 290 PIPETTER
K781883 · JQW
Kallestad Laboratories, Inc.
Chemistry · 27d
Cleared Dec 04, 1978
MINIWASH
K781942 · JTC
Dynatech Laboratories, Inc.
Chemistry · 17d
Cleared Nov 22, 1978
125I-ALDOSTERONE RIA DIAG. KIT
K781504 · CJM
Abbott Laboratories
Chemistry · 84d