Amgen, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Amgen, Inc. - FDA 510(k) Cleared Devices
2
Total
2
Cleared
0
Denied
Amgen, Inc. is a worldwide pioneer in biotechnology with a manufacturing facility in Thousand Oaks, California. The company focuses on innovative therapies across multiple disease areas including oncology, cardiovascular health, bone health, and inflammation.
Amgen received 2 FDA 510(k) clearances from 2 total submissions in the Hematology category. The company's regulatory record spans from 1988 to 1989. This represents a historical record of FDA device clearances; the company has not pursued additional 510(k) submissions in recent years.
The cleared devices included erythropoietin-related products and immunoassay controls used in hematology testing. These submissions reflect Amgen's early involvement in diagnostic and therapeutic protein technologies. Explore the full clearance history, product codes, and submission dates in the database.
FDA 510(k) Regulatory Record - Amgen, Inc.
2 devices