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510(k) K162395

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup by Mp Biomedicals, LLC — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2017
Date Received
August 26, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

Other clearances by Mp Biomedicals, LLC

  • K051958 — MP RAPIDOXY TEST STRIP, MODEL 07RD-7073 (July 21, 2006)

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