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510(k) K052697

HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL by Akers Biosciences, Inc. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2006
Date Received
September 28, 2005
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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