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510(k) K091949

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 by Siemens Healthcare Diagnostics — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2010
Date Received
July 1, 2009
Clearance Type
Special
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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