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510(k) K013124

MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP by Branan Medical Corp. — Product Code DJJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2001
Date Received
September 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometry, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

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