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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
510(k) Number K840769
Device Name PARAMAX ALCOHOL REAGENT
Applicant
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3040
Classification Product Code
DML  
Date Received02/08/1984
Decision Date 04/13/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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