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
11857–11880 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 20, 1980
A-GENT THYROZYME UPTAKE INHIBITOR ASSAY
K800911 · KHQ
Abbott Laboratories
Chemistry · 60d
Cleared Jun 20, 1980
COBAS REAGENT FOR AST (SGOT)
K801118 · CIT
Roche Analytical Instruments, Inc.
Chemistry · 39d
Cleared Jun 20, 1980
TRIGLYCERIDES FOR SMA AND AAII
K801226 · CDT
Reagents Applications, Inc.
Chemistry · 29d
Cleared Jun 20, 1980
COBAS REAGENT FOR ALKALINE PHOSPHATASE
K801242 · CJE
Roche Analytical Instruments, Inc.
Chemistry · 24d
Cleared Jun 20, 1980
ROCHE HCG STANDARDS
K801244 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 24d
Cleared Jun 17, 1980
COBAS REAGENT FOR BUN
K801116 · CDQ
Roche Analytical Instruments, Inc.
Chemistry · 36d
Cleared Jun 17, 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133 · LBS
Union Carbide Corp.
Chemistry · 36d
Cleared Jun 17, 1980
BIOSTATOR PRINTER/PLOTTER
K801210 · JQP
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
BUN-COLOR 2, BLOOD UREA NITROGEN TEST
K800902 · CDL
Sclavo, Inc.
Chemistry · 52d
Cleared Jun 09, 1980
J.T. BAKER LSA 290 PIPETTER/DILUTER
K801090 · JQW
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
K 750 COMPUTER/DATA PROCESSOR
K801091 · JQP
J.T. Baker Chemical Co.
Chemistry · 32d
Cleared Jun 09, 1980
PERKIN ELMER MODEL 91 AMYLASE REAGENT
K801096 · KHM
Stat Engineering
Chemistry · 31d
Cleared Jun 09, 1980
THYROXINE RADIOIMMUNOASSAY KIT
K801105 · CDX
Calbiochem-Behring Corp.
Chemistry · 31d
Cleared Jun 09, 1980
COBAS TOTAL BILIRUBIN REAGENT & DILUENT
K801117 · CIG
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
COBAS REAGENT FOR ALT (GPT)
K801119 · CKA
Roche Analytical Instruments, Inc.
Chemistry · 28d
Cleared Jun 09, 1980
TRIIODOTHYRONINE RADIOIMMUN. SYSTEM
K801123 · CDP
Calbiochem-Behring Corp.
Chemistry · 28d
Cleared Jun 09, 1980
SPAC T3 RIA TEST KIT
K801125 · CDP
Mallinckrodt Critical Care
Chemistry · 28d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 500 ANALYZER
K801139 · JJG
Union Carbide Corp.
Chemistry · 27d
Cleared Jun 09, 1980
SMI MULTI-TUBE VORTEXER
K801145 · JRQ
Scientific Manufacturing Industries
Chemistry · 27d
Cleared Jun 09, 1980
CENTRIFICHEM SYSTEM 400
K801167 · JQP
Union Carbide Corp.
Chemistry · 25d
Cleared Jun 09, 1980
CORTISOL RADIOIMMUNOASSAY KIT
K801203 · CGR
Technia Diagnostics , Ltd.
Chemistry · 21d
Cleared Jun 09, 1980
EMIT DISOPYRAMIDE ASSAY
K801204 · KLR
Syva Co.
Chemistry · 21d
Cleared Jun 09, 1980
MODEL 4900 OFF-LINE PREPARATION SYSTEM
K801271 · JQW
Pm America, Inc.
Chemistry · 12d
Cleared Jun 02, 1980
AMES GLUCOMETER REFLECT. PHOTOMETER
K801044 · JJQ
Miles Laboratories, Inc.
Chemistry · 28d