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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 K915516
Device Name ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact CAROL L KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact CAROL L KRIEGER
Regulation Number862.3280
Classification Product Code
LAS  
Date Received12/09/1991
Decision Date 01/28/1992
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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