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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Phencyclidine
510(k) Number K890882
Device Name ABUSCREEN FP FOR PHENCYCLIDINE
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact ALEX WESOLOWSKI
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact ALEX WESOLOWSKI
Classification Product Code
LCL  
Date Received02/21/1989
Decision Date 03/15/1989
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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