Genchem, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3, CALCIUM, AZO DYE REAGENT, BUN REAGENT
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Genchem, Inc. Chemistry ✕
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