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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
510(k) Number K843378
Device Name ETHYL ALCOHOL ASSAY KIT
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4 Newland Crescent
Charlottetown
Canada, 
Regulation Number862.3040
Classification Product Code
DMT  
Date Received08/28/1984
Decision Date 09/14/1984
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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