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
11761–11784 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Oct 10, 1980
ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO
K802068 · JJX
Beckman Instruments, Inc.
Chemistry · 44d
Cleared Oct 10, 1980
BAKER DIAG. ULTRARATE CHLORIDE KIT
K802080 · JFS
J.T. Baker Chemical Co.
Chemistry · 43d
Cleared Oct 10, 1980
AMERICAN MONITOR MAGNESIUM #'S 1036&4021
K802091 · JGJ
American Monitor Corp.
Chemistry · 38d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL-NORMAL
K802108 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
KEMTROL SERUM CONTROL ABNORMAL
K802109 · JJY
Helena Laboratories
Chemistry · 37d
Cleared Oct 10, 1980
TESTOSTERONE RADIOIMMUNOASSY KIT
K802135 · CDZ
Radioimmunoassay, Inc.
Chemistry · 36d