Elecsys Testosterone II

Radioimmunoassay, Testosterones And Dihydrotestosterone

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Testosterone Ii.

Pre-market Notification Details

Device IDK211685
510k NumberK211685
Device Name:Elecsys Testosterone II
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis,  IN  46250
ContactAdennis N Cora
CorrespondentJustin Davis
Roche Diagnostics 9115 Hague Road, PO Box 50416 Indianapolis,  IN  46250
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-02
Decision Date2022-05-06

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