Affinity Biologicals, Inc. is one of 184 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Affinity Biologicals, Inc. - FDA 510(k) Cleared Devices
5
Total
5
Cleared
0
Denied
Affinity Biologicals, Inc. has 5 FDA 510(k) cleared medical devices. Based in Ancaster, Ontario, CA.
Historical record: 5 cleared submissions from 2005 to 2016. Primary specialty: Hematology.
Browse the FDA 510(k) cleared devices submitted by Affinity Biologicals, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Affinity Biologicals, Inc.
5 devices
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