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510(k) K143500

Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set by Immunalysis Corporation — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2015
Date Received
December 10, 2014
Clearance Type
Traditional
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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