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
12265–12288 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 10, 1979
A-GENT QUANTICHROM T4 11A
K790848 · KLI
Abbott Laboratories
Chemistry · 99d
Cleared Aug 10, 1979
QUANTIMUNE T-3 FIA
K790960 · CDP
Bio-Rad
Chemistry · 80d
Cleared Aug 10, 1979
BILIRUBIN CALIBRATOR CONTROL
K791141 · JJX
Beckman Instruments, Inc.
Chemistry · 53d
Cleared Aug 10, 1979
ANALYZER, SODIUM/POTASSIUM
K791175 · CEM
Nova Biomedical Corp.
Chemistry · 46d
Cleared Aug 10, 1979
CENTRIFICHEM SYSTEM 500
K791180 · JJG
Union Carbide Corp.
Chemistry · 46d
Cleared Aug 10, 1979
PRE-DENT
K791200 · GIM
Fichte, Graves, and Hunt
Chemistry · 43d
Cleared Aug 10, 1979
GLUCOSE (GDH) REAGENT
K791213 · LFR
Gilford Diagnostics
Chemistry · 39d
Cleared Aug 10, 1979
PRISMA
K791297 · JJE
Lkb Instruments, Inc.
Chemistry · 25d
Cleared Aug 03, 1979
KINETIC DETERMINATION OF UV GLUCOSE
K791110 · LFR
The Dow Chemical Co.
Chemistry · 50d
Cleared Aug 03, 1979
BUFFERIZER
K791144 · JJN
Helena Laboratories
Chemistry · 46d
Cleared Aug 03, 1979
CHEMETRICS ANALYZER II
K791296 · JJE
Chemetrics Corp.
Chemistry · 24d
Cleared Jul 30, 1979
QUANTIMUNE T-4 FIA
K790576 · CDX
Bio-Rad
Chemistry · 124d
Cleared Jul 30, 1979
RIA, DIGNXIN-125-I
K790602 · DPB
Endocrine-Metabolic Center
Chemistry · 125d
Cleared Jul 30, 1979
PREG-TEX
K790898 · JHJ
Biologics Intl., Inc.
Chemistry · 82d
Cleared Jul 30, 1979
IMMUNOSPOT TSH TEST
K791065 · JLW
Meloy Laboratories, Inc.
Chemistry · 48d
Cleared Jul 30, 1979
AUTOMATED ELECTROPHORESES MACHINE
K791111 · JJN
Gelman Sciences, Inc.
Chemistry · 46d
Cleared Jul 30, 1979
MACOMB NORMAL CONTROL SERUM
K791119 · JJY
Macomb Chemical Co.
Chemistry · 45d
Cleared Jul 30, 1979
URIDROP SPECIAL
K791197 · KNK
Ab Medett Produkter
Chemistry · 34d
Cleared Jul 30, 1979
HCG RIA PREGNANCY TEST
K791206 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 31d
Cleared Jul 30, 1979
UCG-LYPHOTEST
K791309 · JHJ
Wampole Laboratories
Chemistry · 14d
Cleared Jul 30, 1979
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · KHO
Bio-Rad
Chemistry · 12d
Cleared Jul 24, 1979
RIA, INSULIN, DOUBLE ANTIBODY
K790630 · CFP
Endocrine-Metabolic Center
Chemistry · 119d
Cleared Jul 24, 1979
PROGESTERONE RADIOIMMUNOASSAY KIT
K791051 · JLS
Cis Radiopharmaceuticals, Inc.
Chemistry · 48d
Cleared Jul 24, 1979
BECKMAN ELECTROPHORESIS OVEN/INCUBATOR
K791077 · JRJ
Beckman Instruments, Inc.
Chemistry · 42d