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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K852847
Device Name SOPHEIA DHEA-SO4 EIA KIT
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact SIDNEY A AROESTY
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact SIDNEY A AROESTY
Regulation Number862.1245
Classification Product Code
JKC  
Date Received07/05/1985
Decision Date 08/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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