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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
510(k) Number K854009
Device Name ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
Applicant
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109 -3597
Applicant Contact KAFADER II
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109 -3597
Correspondent Contact KAFADER II
Regulation Number862.3100
Classification Product Code
DJP  
Date Received09/30/1985
Decision Date 10/15/1985
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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