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510(k) K012109

DRI ECSTASY URINE CALIBRATORS by Microgenics Corp. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2001
Date Received
July 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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