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
12745–12768 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 20, 1977
CYSTIC FIBROSIS TESTING INSTRUMENT
K772176 · JJN
Laboratory Equipment Design Co.
Chemistry · 29d
Cleared Dec 06, 1977
AUTOMATIC ANALYZER
K771662 · JJC
Lachat Chemicals, Inc.
Chemistry · 98d
Cleared Dec 06, 1977
LIPASE
K771903 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL KINASE
K771904 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
GLYCEROL SUBSTRATE
K771905 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
PHOSPHATE
K771906 · CDT
Simmler & Son, Inc.
Chemistry · 60d
Cleared Dec 06, 1977
PH CALIBRATION BUFFERS
K772106 · JIT
General Diagnostics
Chemistry · 29d
Cleared Dec 06, 1977
ULTRACHEM TOTAL PROTEIN, #64974
K772155 · CEK
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
ULTRACHEM PHOSPHORUS, 64973
K772156 · CEO
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
CREATININE, 64972
K772157 · CGX
Harleco
Chemistry · 20d
Cleared Dec 06, 1977
DYNAZYME TM II CARDIAK-MB
K772172 · JHW
J.T. Baker Chemical Co.
Chemistry · 15d
Cleared Nov 30, 1977
URINARY VMA - SCREEN TEST KIT
K772151 · CDF
Eppendorf-Brinkmann, Inc.
Chemistry · 15d
Cleared Nov 28, 1977
SPECTROPHOTOMETER ANALYSIS SYS.
K771807 · JJQ
Varian Assoc., Inc.
Chemistry · 63d
Cleared Nov 28, 1977
ENZAC URIC ACID 100-TEST KIT
K772082 · CDH
Bd Becton Dickinson Vacutainer...
Chemistry · 25d
Cleared Nov 28, 1977
CREATININE URINE APPLI.-#32308
K772107 · CGX
Harleco
Chemistry · 21d
Cleared Nov 23, 1977
QUANTROLS HCG
K772086 · JHI
Organon, Inc.
Chemistry · 20d
Cleared Nov 22, 1977
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
K771102 · LFR
The Dow Chemical Co.
Chemistry · 155d
Cleared Nov 22, 1977
CHLORIDE
K771832 · JFS
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
LACTATE DEHYDROGENASE
K771836 · CFJ
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
WETTING AGENTS
K771843
Gamma Enterprises, Inc.
Chemistry · 62d
Cleared Nov 22, 1977
ELECTROTHERM MODELS TC-100 & M-99
K771995 · FLL
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 22, 1977
TELETHERMOMETER MODEL T T-100
K771996 · FLL
Electromedics, Inc.
Chemistry · 32d
Cleared Nov 22, 1977
IN VITRO DIAGNOSTIC REAGENT
K772096 · CDX
Pcl-Ria, Inc.
Chemistry · 15d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP
K772032 · CJE
Harleco
Chemistry · 21d