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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Androstenedione
510(k) Number K844398
Device Name COAT-A-COUNT ANDROSTENEDIONE RIA KIT
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Applicant Contact SIGI ZIERING
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045
Correspondent Contact SIGI ZIERING
Regulation Number862.1075
Classification Product Code
CIZ  
Date Received11/13/1984
Decision Date 12/10/1984
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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