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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
11737–11760 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 31, 1980
CENTRIFICHEM ALBUMIN
K802436 · CIX
Union Carbide Corp.
Chemistry · 25d
Cleared Oct 31, 1980
GESTATE SLIDE EIKEN KIT AGG. METHOD HUM
K802450 · JHJ
Syn-Kit, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
ESTRIOL-SQUIBB RIA KIT
K802455 · CGI
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
T4-SQUIBB RIA KIT
K802456 · CDX
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
OREAI-Q-TU TEST
K802464 · KHQ
Organon, Inc.
Chemistry · 22d
Cleared Oct 31, 1980
TSH RADIOIMMUNOASSAY KIT
K802467 · JLW
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 31, 1980
T3 UPTAKE TEST SYSTEM
K802468 · KHQ
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 31, 1980
DRUG DETECTION SYSTEM
K802619 · JJQ
Syva Co.
Chemistry · 11d
Cleared Oct 23, 1980
KLINAR REAGENT PAK, #36010
K801892 · JGT
Hi Chem, Inc.
Chemistry · 76d
Cleared Oct 23, 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · CGR
Corning Medical & Scientific
Chemistry · 62d
Cleared Oct 23, 1980
DEHYDROEPIANDROSTERONE SULFATE KIT RIA
K802195 · JKC
Radioassay Systems Laboratories, Inc.
Chemistry · 43d
Cleared Oct 23, 1980
SURETY COLUMN
K802209 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
SERUM SEPARATOR
K802211 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
ANALYTE T3 UPTAKE
K802246 · KHQ
Technicon Instruments Corp.
Chemistry · 37d
Cleared Oct 23, 1980
SP 120 SOPHISTICATE
K802251 · JQP
Vickers America Medical Corp.
Chemistry · 37d
Cleared Oct 23, 1980
TRIGLYCERIDES DETERMINATION
K802256 · CDT
Coleman Laboratories Corp.
Chemistry · 37d
Cleared Oct 23, 1980
IL TOTAL PROTEIN REAGENT
K802310 · CEK
Instrumentation Laboratory CO
Chemistry · 30d
Cleared Oct 23, 1980
URIC ACID/ALDH
K802371 · CDO
Boehringer Mannheim Corp.
Chemistry · 24d
Cleared Oct 23, 1980
KODAK EKTA-CHEM CLINICAL CHEM. SLIDES
K802376 · CHS
Eastman Kodak Company
Chemistry · 23d
Cleared Oct 23, 1980
ASTRA PRINTER PAPER #88112-CHLORIDE SILV
K802392 · JJF
Hi Chem, Inc.
Chemistry · 21d
Cleared Oct 23, 1980
UCG-BETA STAT
K802421 · JHJ
Armkel, LLC
Chemistry · 17d
Cleared Oct 23, 1980
UCG-BETA SLIDE
K802435 · JHJ
Armkel, LLC
Chemistry · 17d
Cleared Oct 10, 1980
GLUCOSE DIAGNOSTIC REAGENT
K801897 · CGA
Connecticut Diagnostics, Ltd.
Chemistry · 63d
Cleared Oct 10, 1980
URIC ACID DIAGNOSTIC REAGENT
K801898 · KNK
Connecticut Diagnostics, Ltd.
Chemistry · 63d