Genchem, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genchem, Inc. - FDA 510(k) Cleared Devices
8
Total
8
Cleared
0
Denied
Genchem, Inc. has 8 FDA 510(k) cleared medical devices. Based in Brea, US.
Historical record: 8 cleared submissions from 2004 to 2009. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Genchem, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genchem, Inc.
8 devices
Cleared
Jun 05, 2009
CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
Chemistry
120d
Cleared
Dec 27, 2004
CALCIUM, AZO DYE REAGENT
Chemistry
257d
Cleared
Dec 27, 2004
BUN REAGENT
Chemistry
257d
Cleared
Dec 27, 2004
GLUCOSE OXIDASE, GLUCOSE
Chemistry
257d
Cleared
Dec 27, 2004
GENCHEM CO2 ACID REAGENT
Chemistry
257d
Cleared
Dec 27, 2004
GENCHEM CREATININE REAGENT
Chemistry
257d
Cleared
Dec 27, 2004
GENCHEM ELECTROLYTE BUFFER
Chemistry
257d
Cleared
Dec 22, 2004
GENCHEM ISE ELECTROLYTE REFERENCE
Chemistry
252d