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510(k) K874382

RAICHEM(TM) ALCOHOL REAGENT by Reagents Applications, Inc. — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1988
Date Received
October 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Device Class
Class II
Regulation Number
862.3040
Review Panel
TX
Submission Type

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