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510(k) K123947

ARCHITECT IVANCOMYCIN by Biokit, S.A. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2013
Date Received
December 21, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Vancomycin
Device Class
Class II
Regulation Number
862.3950
Review Panel
TX
Submission Type

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