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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 K800514
Device Name PHENCYCLIDINE DIRECT BLOOD RIA KIT
Applicant
Immunalysis Corporation
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Immunalysis Corporation
4221 Richmond Rd., NW
Walker,  MI  49534
Classification Product Code
LCL  
Date Received03/05/1980
Decision Date 03/19/1980
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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