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510(k) K110432

VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN by Affinity Biologicals, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2011
Date Received
February 15, 2011
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

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  • 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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