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510(k) K092273

RANDOX ETHANOL ASSAY by Randox Laboratories, Ltd. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2010
Date Received
July 28, 2009
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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