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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 K121247
Device Name ALCO-SCREEN
Applicant
Chematics, Inc.
P.O. Box 293
Highway 13 S.
North Webster,  IN  46555
Applicant Contact CARL REYNOLDS
Correspondent
Chematics, Inc.
P.O. Box 293
Highway 13 S.
North Webster,  IN  46555
Correspondent Contact CARL REYNOLDS
Regulation Number862.3040
Classification Product Code
DIC  
Date Received04/25/2012
Decision Date 03/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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