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510(k) K032461

ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 by Lin-Zhi International, Inc. — Product Code DIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2003
Date Received
August 11, 2003
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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