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510(k) K150502

DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls by Microgenics Corporation — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2015
Date Received
February 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Opiates
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type

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