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510(k) K151771

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators by Immunalysis Corporation — Product Code JXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2016
Date Received
June 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Benzodiazepine
Device Class
Class II
Regulation Number
862.3170
Review Panel
TX
Submission Type

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