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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 K014120
Device Name TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
Applicant
Diagnostics Biochem Canada, Inc.
1020 Hargrieve Rd.
London, Ontario,  CA N6E 1P5
Applicant Contact G. R. DUMONT
Correspondent
Diagnostics Biochem Canada, Inc.
1020 Hargrieve Rd.
London, Ontario,  CA N6E 1P5
Correspondent Contact G. R. DUMONT
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received12/17/2001
Decision Date 02/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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