ADVIA CENTAUR TSH

Radioimmunoassay, Thyroid-stimulating Hormone

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 Tsh.

Pre-market Notification Details

Device IDK141999
510k NumberK141999
Device Name:ADVIA CENTAUR TSH
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactAlex Hsu
CorrespondentAlex Hsu
Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-23
Decision Date2015-04-22
Summary:summary

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