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510(k) K150144

VisuCon-F Low Fibrinogen Control Plasma by Affinity Biologicals, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2016
Date Received
January 22, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Affinity Biologicals, Inc.

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  • K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONT (October 28, 2009)
  • K052825 — VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG (January 20, 2006)
  • K051054 — VISULIZE FACTOR IX ANTIGEN KIT (June 29, 2005)

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