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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 K972725
Device Name ALCOHOL REAGENT SET
Applicant
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Applicant Contact WILLIAM F WALTERS
Correspondent
Pointe Scientific, Inc.,
1025 John A. Papalas Dr.
Lincoln Park,  MI  48146
Correspondent Contact WILLIAM F WALTERS
Regulation Number862.3040
Classification Product Code
DIC  
Date Received07/21/1997
Decision Date 09/25/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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