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Affinity Biologicals, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K150144 VisuCon-F Low Fibrinogen Control PlasmaGGN2016-03-06 View
510(k) K110432 VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABNGGN2011-10-20 View
510(k) K091284 VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMAGGN2009-10-28 View
510(k) K052825 VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGGGP2006-01-20 View
510(k) K051054 VISULIZE FACTOR IX ANTIGEN KITGGP2005-06-29 View
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