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510(k) K123933

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE by Siemens Healthcare Diagnostics, Inc. — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2013
Date Received
December 20, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panels, Test, Susceptibility, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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