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510(k) K093626

INNOVANCE D-DIMER, MODEL OPBP09 by Siemens Healthcare Diagnostics — Product Code DAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2010
Date Received
November 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7320
Review Panel
HE
Submission Type

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