Medical Device Manufacturer · US , Thousand Oaks , CA

Amgen, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1988

Recent clearances: CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3, ERYTHROPOIETIN ENZYME IMMUNOASSAY

View 2 510(k) Devices ↓ Official Website

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amgen, Inc. Hematology ✕

2 devices

1-2 of 2

Cleared Oct 10, 1989

CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3

Hematology · 68d

Cleared Dec 20, 1988

ERYTHROPOIETIN ENZYME IMMUNOASSAY

Hematology · 173d