Medical Device Manufacturer · CA , Ancaster, Ontario

Affinity Biologicals, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2005

5

Total

5

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Mar 06, 2016

VisuCon-F Low Fibrinogen Control Plasma

Hematology · 409d

Cleared Oct 20, 2011

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN

Hematology · 247d

Cleared Oct 28, 2009

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL...

Hematology · 180d

Cleared Jan 20, 2006

VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

Hematology · 107d

Cleared Jun 29, 2005

VISULIZE FACTOR IX ANTIGEN KIT

Hematology · 64d