Medical Device Manufacturer · US , West Lafayette , IN

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

5 submissions · 5 cleared · Since 1994

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hemocleanse, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Sep 10, 1999

BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)

Gastroenterology & Urology · 72d

Cleared Aug 13, 1999

BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL...

Gastroenterology & Urology · 234d

Cleared Feb 15, 1996

BIOLOGIC-DT SYSTEM

Gastroenterology & Urology · 189d

Cleared Sep 30, 1994

BIOLOGIC DT-1000 MACHINE

Gastroenterology & Urology · 828d