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510(k) K150925

Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set by Immunalysis Corporation — Product Code DIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2015
Date Received
April 6, 2015
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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