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510(k) K091284

VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA by Affinity Biologicals, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2009
Date Received
May 1, 2009
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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