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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
Applicant Contact KAFADER II
Correspondent
Roche Diagnostic Systems, Inc.
11 Franklin Ave.
Belleville,  NJ  07109
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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