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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Specific Control Materials
510(k) Number K930844
Device Name ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
Applicant
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
1080 Us Highway 202
Branchburg,  NJ  08876 -3771
Correspondent Contact CAROL L KRIEGER
Regulation Number862.3280
Classification Product Code
LAS  
Date Received02/18/1993
Decision Date 01/27/1994
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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