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510(k) K240670

DRI Ecstasy Plus Assay by Microgenics Corporation — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2024
Date Received
March 11, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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