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
12169–12192 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 17, 1979
BE-SURE
K791706 · JHJ
Precision Products Corp.
Chemistry · 61d
Cleared Oct 17, 1979
CENTRIA INSULIN RIA
K791707 · CFP
Ventrex Laboratories, Inc.
Chemistry · 50d
Cleared Oct 17, 1979
CENTRIA TSH RIA
K791855 · JLW
Union Carbide Corp.
Chemistry · 28d
Cleared Oct 17, 1979
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
K791874 · JIX
Gilford Diagnostics
Chemistry · 26d
Cleared Oct 17, 1979
SERACON - EL DO27
K791958 · JJY
Bhp Diagnostix, Inc.
Chemistry · 16d
Cleared Oct 17, 1979
EIA (ELISA) READER
K791968 · JJQ
Gilford Instrument Laboratories, Inc.
Chemistry · 16d
Cleared Oct 17, 1979
TECHNICON C202 SYSTEM
K791989 · CGA
Technicon Instruments Corp.
Chemistry · 14d
Cleared Oct 17, 1979
TECHNICON HDL CHOLESTEROL METHOD
K791990 · LBS
Technicon Instruments Corp.
Chemistry · 14d
Cleared Oct 17, 1979
CREATININE DIAG. REAGENT PICRIC ACID
K791994 · CGX
Connecticut Diagnostics, Ltd.
Chemistry · 14d
Cleared Oct 11, 1979
AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM
K791375 · CDP
Micromedic Systems
Chemistry · 79d
Cleared Oct 11, 1979
SERACON CAL D025
K791956 · JIX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 11, 1979
SERACON -LO DO26
K791957 · JJX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 02, 1979
BE-SURE
K791609 · JHJ
Biologics Intl., Inc.
Chemistry · 53d
Cleared Oct 01, 1979
IMMUCHEM COVALENT COAT SOLID PHASE ASSAY
K791663 · CDP
Immuchem Corp.
Chemistry · 41d
Cleared Oct 01, 1979
CORTI-SHURE
K791700 · CGR
Nuclear Medical Laboratories, Inc.
Chemistry · 33d
Cleared Oct 01, 1979
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723 · JJT
Organon, Inc.
Chemistry · 32d
Cleared Oct 01, 1979
ADDITIVE HINGE CAP
K791796 · KPE
Abbott Laboratories
Chemistry · 17d
Cleared Oct 01, 1979
LY-PRO-TROL #ACS-LP101
K791825 · JJY
Analytical Control Systems, Inc.
Chemistry · 14d
Cleared Oct 01, 1979
CPK CLINI GEL KIT
K791826 · JHT
Clinical Sciences, Inc.
Chemistry · 14d
Cleared Oct 01, 1979
LDH CLINI GEL KIT
K791827 · CFE
Clinical Sciences, Inc.
Chemistry · 14d
Cleared Oct 01, 1979
QUANTIMUNE HFSH RIA
K791836 · CGJ
Bio-Rad
Chemistry · 17d
Cleared Oct 01, 1979
CENTRIA HPL RIA
K791854 · JMF
Union Carbide Corp.
Chemistry · 12d
Cleared Oct 01, 1979
GLUCOSE OXIDASE (FRINDER) KIT
K791869 · CGA
Mid Tech, Inc.
Chemistry · 11d
Cleared Sep 27, 1979
AUTO PAK VITAMIN B-12
K790347 · CDD
Micromedic Systems
Chemistry · 218d