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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 K874382
Device Name RAICHEM(TM) ALCOHOL REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.3040
Classification Product Code
DML  
Date Received10/26/1987
Decision Date 01/11/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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