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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 K894001
Device Name SALIVA ALCOHOL TEST
Applicant
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
355 Business Center Dr.
Horsham,  PA  19044
Applicant Contact CHRISTOPHER ZALESKY
Correspondent
Enzymatics C/O Burditt,Bowles,Radzius & Ruberry
355 Business Center Dr.
Horsham,  PA  19044
Correspondent Contact CHRISTOPHER ZALESKY
Regulation Number862.3040
Classification Product Code
DIC  
Date Received06/05/1989
Decision Date 04/05/1990
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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