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510(k) K040411

DRI OXYCODONE ASSAY by Microgenics Corp. — Product Code LAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2004
Date Received
February 18, 2004
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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