Medical Device Manufacturer · US , Brea , CA

Elan Pharma, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Elan Pharma, Inc. Chemistry ✕

4 devices

1-4 of 4

Cleared Aug 19, 1998

HICHEM CHOLESTEROL REAGENT KIT

Chemistry · 35d

Cleared Jun 29, 1998

HICHEM PHOSPHORUS REAGENT KIT

Chemistry · 41d

Cleared Aug 15, 1996

HICHEM CK/NAC REAGENT KIT

Chemistry · 65d

Cleared Mar 29, 1996

HICHEM BUN/UREA REAGENT KIT

Chemistry · 78d