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510(k) K113751

RANDOX COCAINE METABOLITE by Randox Laboratories, Ltd. — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2012
Date Received
December 21, 2011
Clearance Type
Traditional
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

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