ADVIA CENTAUR TESTOSTERONE (TSTO)

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 (tsto).

Pre-market Notification Details

Device IDK133491
510k NumberK133491
Device Name:ADVIA CENTAUR TESTOSTERONE (TSTO)
ClassificationRadioimmunoassay, Testosterones And Dihydrotestosterone
Applicant Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
ContactMatthew Gee
CorrespondentMatthew Gee
Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVENUE Tarrytown,  NY  10591 -5097
Product CodeCDZ  
CFR Regulation Number862.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-13
Decision Date2014-02-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.