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510(k) K101434

AUDIT MICROCV PROCALCITONIN LINEARITY by Aalto Scientific, Ltd. — Product Code MJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2010
Date Received
May 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

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