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FDA 510(k) Applications Submitted by AFFINITY BIOLOGICALS INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150144
01/22/2015
VisuCon-F Low Fibrinogen Control Plasma
AFFINITY BIOLOGICALS INC.
K110432
02/15/2011
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
AFFINITY BIOLOGICALS INC.
K051054
04/26/2005
VISULIZE FACTOR IX ANTIGEN KIT
AFFINITY BIOLOGICALS INC.
K091284
05/01/2009
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
AFFINITY BIOLOGICALS INC.
K052825
10/05/2005
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
AFFINITY BIOLOGICALS INC.
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