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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 K863419
Device Name EMDS(TM) ALCOHOL TESTPACKS, #67691/95
Applicant
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact RAYMOND L MILLER
Correspondent
Em Diagnostic Systems, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact RAYMOND L MILLER
Regulation Number862.3040
Classification Product Code
DML  
Date Received09/03/1986
Decision Date 09/29/1986
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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