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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 K862218
Device Name DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact SMITH, PHD
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact SMITH, PHD
Regulation Number862.3250
Classification Product Code
KLN  
Date Received06/11/1986
Decision Date 06/27/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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