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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 K211685
Device Name Elecsys Testosterone II
Applicant
Roche Diagnostics
9115 Hague Road, PO Box 50416
Indianapolis,  IN  46250
Applicant Contact Adennis N Cora
Correspondent
Roche Diagnostics
9115 Hague Road, PO Box 50416
Indianapolis,  IN  46250
Correspondent Contact Justin Davis
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received06/02/2021
Decision Date 05/06/2022
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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