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510(k) K063053

MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) by Dade Behring, Inc. — Product Code LRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2006
Date Received
October 4, 2006
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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