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510(k) K091264

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 by Siemens Healthcare Diagnostics — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2009
Date Received
April 30, 2009
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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