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510(k) K030616

CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 by Microgenics Corp. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2003
Date Received
February 26, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drug Specific Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

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