Medical Device Manufacturer · US , Waltham , MA

Hemagen Diagnostics, Inc. - FDA 510(k) Cleared Devices

52 submissions · 52 cleared · Since 1986

Total

Cleared

Denied

Hemagen Diagnostics, Inc. was founded in 1985 by scientists from Boston University School of Medicine. The company provides clinical diagnostic solutions specializing in immunology devices for autoimmune and infectious disease testing. Hemagen offers gold standard IFA products, ELISA, HA, and point-of-care testing formats for human and veterinary diagnostics.

Hemagen has received 52 FDA 510(k) clearances from 52 total submissions since its first clearance in 1986. The company's regulatory portfolio focuses on immunology devices, including antibody detection kits, autoimmune screening assays, and related diagnostic products. The latest clearance on record dates to 2004, reflecting the company's historical role in diagnostic device development.

Notable cleared devices include VIRGO Beta 2 Glycoprotein antibody kits, VIRGO ANCA Screen Kit, PR3 Antibody Kit, and anti-cardiolipin screening assays. These products represent Hemagen's core expertise in autoimmune disease serology and infectious disease diagnostics.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the 510(k) database.

Hemagen Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.