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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
510(k) Number K934275
Device Name PARAMAX ALCOHOL REAGENT
Applicant
Baxter Diagnostics, Inc.
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact SCOTT BEGGINS
Correspondent
Baxter Diagnostics, Inc.
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact SCOTT BEGGINS
Regulation Number862.3040
Classification Product Code
DIC  
Date Received08/31/1993
Decision Date 04/26/1994
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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