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510(k) K083262

MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) by Siemens Healthcare Diagnostics — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2009
Date Received
November 5, 2008
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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