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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, cannabinoid(s)
510(k) Number K912574
Device Name ABUSCREEN ONLINE FOR THC (50 AND 100)
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 Number862.3870
Classification Product Code
LAT  
Date Received06/12/1991
Decision Date 08/12/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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