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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
510(k) Number K912754
Device Name ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact CAROL KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact CAROL KRIEGER
Regulation Number862.3100
Classification Product Code
DPJ  
Date Received06/21/1991
Decision Date 09/27/1991
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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