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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, Cannabinoids
510(k) Number K871695
Device Name DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact PAUL DURHAM
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact PAUL DURHAM
Regulation Number862.3870
Classification Product Code
LDJ  
Date Received04/30/1987
Decision Date 06/05/1987
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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