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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Cocaine Metabolite
510(k) Number K870740
Device Name COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact PAUL DURHAM
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact PAUL DURHAM
Regulation Number862.3250
Classification Product Code
KLN  
Date Received02/25/1987
Decision Date 03/19/1987
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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