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510(k) K081013

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN by Siemens Healthcare Diagnostics — Product Code LRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2008
Date Received
April 9, 2008
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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