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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Phencyclidine
510(k) Number K873756
Device Name LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact B ASARCH,PHD
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact B ASARCH,PHD
Classification Product Code
LCM  
Date Received09/04/1987
Decision Date 10/15/1987
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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