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
12001–12024 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 05, 1980
WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3
K800296 · GGM
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 05, 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
K800297 · CEO
Sandare Chemical Co., Inc.
Chemistry · 23d
Cleared Mar 05, 1980
AMERLEX T-4 RIA KIT
K800300 · CDX
Amersham Corp.
Chemistry · 23d
Cleared Mar 05, 1980
SIGMA PROCEDURE & REAGENT SYSTEM #335-UV
K800301 · CDT
Sigma Chemical Co.
Chemistry · 23d
Cleared Mar 03, 1980
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559 · GQL
Intl. Diagnostic Technology
Chemistry · 83d
Cleared Mar 03, 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 03, 1980
MICRO MEDICAL DATA SYSTEM II
K800242 · JQP
Micro/Tel., Inc.
Chemistry · 27d
Cleared Mar 03, 1980
EMIT AUTO CORTISOL ASSAY
K800245 · CGR
Syva Co.
Chemistry · 27d
Cleared Feb 26, 1980
SODIUM/POTASSIUM CONDITIONING REAGENT
K800216 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CHLORIDE REAGENT, CUP & CLEANER
K800217 · JFS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CARBON DIOXIDE CUP REAGENT & REF.RGT.
K800218 · JFL
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
SERUM CREATININE
K800219 · CGX
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
CALIBRATOR NO. 1 & 2, & WASH SOLUTION
K800220 · JIT
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Feb 26, 1980
MICRO MEDICAL DATA SYSTEM
K800241 · JQP
Micro/Tel., Inc.
Chemistry · 21d
Cleared Feb 26, 1980
COROMETRICS MEDICAL SYSTEMS 220 PH SYS.
K800271 · CHL
Transidyne General Corp.
Chemistry · 20d
Cleared Feb 22, 1980
RADIOMETER ACID BASE LABORATORY-ABL-3
K800224 · CHL
The London Co.
Chemistry · 17d
Cleared Feb 21, 1980
LINEAR ENZYMATIC CHOLESTEROL SYSTEM
K800199 · CHH
Simmler, Inc.
Chemistry · 22d
Cleared Feb 21, 1980
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200 · CGA
Simmler, Inc.
Chemistry · 22d
Cleared Feb 13, 1980
CALBIOCHEM-BEHRING RIA-COUNT
K792460 · CDD
Calbiochem-Behring Corp.
Chemistry · 72d
Cleared Feb 13, 1980
MICROMEDIC PUNCH & ELUTER
K800075 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Feb 13, 1980
SYSTEM 203 CHEMISTRY ANALYZER
K800085 · JJE
Gilford Instrument Laboratories, Inc.
Chemistry · 30d
Cleared Feb 13, 1980
LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
K800106 · CEP
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
FOLLICLE STIMULATING HORMONE
K800107 · CGJ
Radioimmunoassay, Inc.
Chemistry · 28d
Cleared Feb 13, 1980
CO2 CONTENT
K800111 · CIL
American Monitor Corp.
Chemistry · 28d