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510(k) K062840

TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS by Biosite Incorporated — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2007
Date Received
September 22, 2006
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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