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
12745–12768 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
K772033 · JMK
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1
K772034
Harleco
Chemistry · 21d
Cleared Nov 17, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035 · JFJ
Harleco
Chemistry · 21d
Cleared Nov 15, 1977
TELETHERMOMETER MODEL T T-400
K771997 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
TEMP-A-LERT MODEL TA-986
K771998 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
ELECTROTHERM MODELS F&C18,14,78, F84
K771999 · FLL
Electromedics, Inc.
Chemistry · 25d
Cleared Nov 15, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH
K772028 · CFJ
Harleco
Chemistry · 19d
Cleared Nov 15, 1977
GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT
K772029 · CIT
Harleco
Chemistry · 19d
Cleared Nov 14, 1977
IRON SET, ITEM NO. 65008
K771927 · JMO
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
CALCIUM SET, ITEM NO. 65004
K771928 · CJY
Harleco
Chemistry · 31d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT
K772030 · CKA
Harleco
Chemistry · 18d
Cleared Nov 14, 1977
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT
K772031
Harleco
Chemistry · 18d
Cleared Nov 11, 1977
TMA BICARBONATE/GLYCEROL DILUENT
K771700
Hyland Therapeutic Div., Travenol...
Chemistry · 65d
Cleared Nov 11, 1977
FASTCHEM BUN
K771923 · CDQ
Boehringer Mannheim Corp.
Chemistry · 29d
Cleared Nov 11, 1977
TOTAL PROTEIN SET, ITEM NO. 64010
K771926 · CEK
Harleco
Chemistry · 28d
Cleared Nov 11, 1977
SPECTROPHOTOMETER CARY 219
K772022 · JJQ
Varian Assoc., Inc.
Chemistry · 16d
Cleared Nov 11, 1977
URIC ACID STD. FOR QUANT. URIC ACID
K772025 · JIS
Worthington Biochemical Corp.
Chemistry · 15d
Cleared Nov 09, 1977
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · GKL
Coulter Electronics, Inc.
Chemistry · 93d