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510(k) K840769

PARAMAX ALCOHOL REAGENT by American Dade — Product Code DML

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
February 8, 1984
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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