FDA 510(k) Applications Submitted by DENISE FOULON

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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