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
11737–11760 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 12, 1980
T4 RADIOIMMUNOASSAY KIT
K802469 · CDX
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
T3 RADIOIMMUNOASSAY KIT
K802470 · CDP
American Diagnostic Corp.
Chemistry · 34d
Cleared Nov 12, 1980
CHEMTROLER
K802471 · JQP
Fletcher Flora Computer Products, Inc.
Chemistry · 34d
Cleared Nov 12, 1980
CENTRIFICHEM PIPETTOR ACCURACY CALIB.
K802520 · JQW
Union Carbide Corp.
Chemistry · 28d
Cleared Nov 12, 1980
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572 · CFJ
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Nov 12, 1980
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574 · CJE
Beckman Instruments, Inc.
Chemistry · 26d
Cleared Nov 12, 1980
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581 · JFJ
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Nov 12, 1980
PARAGON SERUM PROTEIN ELECTROPHORESIS
K802592 · CEF
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Nov 12, 1980
BECKMAN DP-5500 DATA REDUCTION SYSTEM
K802594 · JQP
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Nov 12, 1980
CYBREX AMIKACIN
K802669 · KLQ
Abbott Laboratories
Chemistry · 16d
Cleared Oct 31, 1980
ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
K801729 · CIZ
Diagnostics Biochem Canada, Inc.
Chemistry · 99d
Cleared Oct 31, 1980
ICA1 IONIZED CALCIUM ANALYZER
K801848 · JFP
The London Co.
Chemistry · 88d
Cleared Oct 31, 1980
WASH SOLUTION KIT, #88102
K802264 · JJF
Hi Chem, Inc.
Chemistry · 45d
Cleared Oct 31, 1980
COULTER DACOS SERUM CHEM. ANALYZER
K802320 · JJE
Coulter Electronics, Inc.
Chemistry · 38d
Cleared Oct 31, 1980
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
K802379 · LCH
American Instrument Co.
Chemistry · 31d
Cleared Oct 31, 1980
ARIA II 125 I CORTISOL
K802380 · CGR
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Oct 31, 1980
ELECTROLY TE CHEMISTRY ANALYZER
K802398 · JJF
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Oct 31, 1980
CENTRIFICHEM INORGANIC PHOSPHORUS
K802420 · CED
Union Carbide Corp.
Chemistry · 25d
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