Affinity Biologicals, Inc.

Medical device manufacturer in Ancaster, CA.

5510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K150144VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional 03/06/2016SE
K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnGGN · Traditional 10/20/2011SE
K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaGGN · Traditional 10/28/2009SE
K052825Visulize Factor Viii Antigen Kit, Model Fviii-AgGGP · Traditional 01/20/2006SE
K051054Visulize Factor Ix Antigen KitGGP · Traditional 06/29/2005SE