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510(k) K974002

ETHANOL-SL ASSAY, CATALOGUE NUMBER 240-12 by Diagnostic Chemicals , Ltd. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1998
Date Received
October 21, 1997
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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