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510(k) K111677

MICROSCAN(R) MICROSTREP PLUS(R) by Siemens Healthcare Diagnostics, Inc. — Product Code LRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2011
Date Received
June 15, 2011
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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