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510(k) K192943

CEDIA Heroin Metabolite (6-AM) assay by Microgenics Corporation — Product Code DJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2019
Date Received
October 18, 2019
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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