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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
510(k) Number K872180
Device Name KINETIC 610 ETHANOL
Applicant
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Applicant Contact LUANN OCHS
Correspondent
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Correspondent Contact LUANN OCHS
Regulation Number862.3040
Classification Product Code
DML  
Date Received06/08/1987
Decision Date 07/07/1987
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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