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510(k) K101425

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES by Siemens Healthcare Diagnostics — Product Code LRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2010
Date Received
May 20, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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