ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG

Radioimmunoassay, Testosterones And Dihydrotestosterone

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Centaur Testosterone Ii (tstii), Advia Centaur Shbg.

Pre-market Notification Details

Device IDK191533
510k NumberK191533
Device Name:ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactPaul Dasilva
CorrespondentPaul Dasilva
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2019-08-28

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