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510(k) K955633

ENTHANOL (RATE) ASSAY, CATALOGUE NO. 219-03 by Diagnostic Chemicals , Ltd. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1996
Date Received
December 11, 1995
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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