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510(k) K181553

Immunalysis Ethyl Alcohol Enzyme Assay by Immunalysis Corporation — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2018
Date Received
June 13, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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