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510(k) K100716

AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 by Aalto Scientific, Ltd. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2011
Date Received
March 12, 2010
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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