Medical Device Manufacturer · US , Mchenry , IL

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

49 submissions · 49 cleared · Since 1983

49

Total

49

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Oct 01, 2010

ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

Hematology · 92d

Cleared Jun 24, 2002

MEDICA EASYQC HEMATOCRIT CONTROL

Hematology · 13d

Cleared Mar 01, 1996

RNA MEDICAL HEMAT CONTROL

Hematology · 81d

Cleared Jul 18, 1983

Hematology · 35d