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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 K093421
Device Name ELECSYS TESTOSTERONE II IMMUNOASSAY
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
PO BOX 50410
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact Sarah Baumann
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
PO BOX 50410
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact Sarah Baumann
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received11/03/2009
Decision Date 04/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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