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
11809–11832 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 26, 1980
CONICAL TIPPED CENTRIFUGE TUBE 15M
K802210 · JQC
Scientific Specialties, Inc.
Chemistry · 14d
Cleared Sep 16, 1980
BLOOD GLUCOSE TESTER
K801536 · JJQ
Broomer Research Corp.
Chemistry · 75d
Cleared Sep 16, 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735 · CGI
Bd Becton Dickinson Vacutainer...
Chemistry · 53d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM
K801749 · CEK
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY
K801750 · CIX
Beckman Instruments, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
GLUCOSE REAGENT(UV-HEXOKINASE)
K801765 · CFR
Reagents Applications, Inc.
Chemistry · 50d
Cleared Sep 16, 1980
BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.
K801795 · JGS
J.T. Baker Chemical Co.
Chemistry · 49d
Cleared Sep 16, 1980
WAKO HDL CHOLESTEROL TEST
K801834 · LBS
Wako Pure Chemical Industries, Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
T3(125) RADIOIMMUNOASSAY KIT
K801843 · CDP
Technia Diagnostics , Ltd.
Chemistry · 46d
Cleared Sep 16, 1980
LACTI-QUANT
K801849 · CFT
Nuclear Medical Laboratories, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
CENTRIFICHEM PIPETTOR 1000
K801851 · JQW
Union Carbide Corp.
Chemistry · 43d
Cleared Sep 16, 1980
SPINAL FLUID CONTROL(HUMAN)
K801854 · JJX
Environmental Chemical Specialties
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME AST(GOT) PROCEDURE
K801856 · CIT
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
DATA-ZYME LAT(GPT) PROCEDURE
K801857 · CKA
Data Medical Associates, Inc.
Chemistry · 43d
Cleared Sep 16, 1980
NOVA 4 SODIUM/POTASSIUM/CHLORIDE/CARBON
K801882 · JGS
Nova Biomedical Corp.
Chemistry · 40d
Cleared Sep 16, 1980
WAKO TRIGLYCERIDE-G TEST
K801891 · CDT
Wako Pure Chemical Industries, Ltd.
Chemistry · 39d
Cleared Sep 16, 1980
CORNING 60 VOLT POWER SUPPLY
K801893 · JJN
Corning Medical & Scientific
Chemistry · 39d
Cleared Sep 16, 1980
BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM
K801896 · JGS
Beckman Instruments, Inc.
Chemistry · 39d
Cleared Sep 09, 1980
ASSURE LEVEL I PROD. #30171
K801538 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
ASSURE LEVEL II PROD. #30172
K801539 · JJY
Warner-Lambert Co.
Chemistry · 68d
Cleared Sep 09, 1980
HDL CHOLESTEROL TEST KIT
K801726 · LBS
Mallinckrodt Critical Care
Chemistry · 47d
Cleared Sep 09, 1980
DATA-ZYME UREA NITROGEN, COLORIMETRIC
K801727 · CDL
Data Medical Associates, Inc.
Chemistry · 47d
Cleared Aug 27, 1980
GLUCOSE (TRINDER) REAGENT
K801600 · CGA
Gilford Diagnostics
Chemistry · 44d
Cleared Aug 27, 1980
TESTOSTERONE KIT
K801666 · CDZ
Immuchem Corp.
Chemistry · 37d