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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 K830481
Device Name ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
Applicant
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hoffmann-La Roche, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LCL  
Date Received02/15/1983
Decision Date 03/24/1983
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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