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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K032881
Device Name IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
Applicant
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Applicant Contact EDWARD M LEVINE
Correspondent
Diagnostic Products Corp.
5700 W. 96th St.
Los Angeles,  CA  90045 -5597
Correspondent Contact EDWARD M LEVINE
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received09/15/2003
Decision Date 10/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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