Medical Device Manufacturer · US , Waltham , MA

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

52 submissions · 52 cleared · Since 1986

Recent clearances: RAICHEM BUN RATE REAGENT (LIQUID), RAICHEM GLUCOSE UV (LIQUID), RAICHEM CALCIUM (OCPC) LIQUID REAGENT

Official Website

52

Total

52

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hemagen Diagnostics, Inc. Immunology ✕

35 devices

1-12 of 35

Cleared Aug 30, 1999

VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT

Immunology · 60d

Cleared Aug 30, 1999

VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT

Immunology · 60d

Cleared Aug 30, 1999

VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT

Immunology · 60d

Cleared Nov 13, 1997

VIRGO ANCA SCREEN KIT

Immunology · 37d

Cleared Nov 13, 1997

PR 3 ANTIBODY KIT

Immunology · 37d

Cleared Nov 13, 1997

VIRGO PANCO KIT

Immunology · 37d

Cleared Aug 28, 1997

RAICHEM PREALBUMIN SPIA

Immunology · 31d

Cleared Jun 20, 1997

VIRGO AMA ELISA KIT

Immunology · 28d

Cleared Jun 03, 1997

HEMAGEN ANTI CARDIOLIPIN SCREEN

Immunology · 74d

Cleared Dec 05, 1996

HEMAGEN ENA DSDNA KIT (EIA METHOD)

Immunology · 175d

Cleared Sep 12, 1996

HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)

Immunology · 52d

Cleared Mar 12, 1996

HEMAGEN CRP 150 KIT (EIA METHOD)

Immunology · 49d