ADVIA Centaur Total IgE (tIgE)

Ige, Antigen, Antiserum, Control

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 Total Ige (tige).

Pre-market Notification Details

Device IDK193493
510k NumberK193493
Device Name:ADVIA Centaur Total IgE (tIgE)
ClassificationIge, Antigen, Antiserum, Control
Applicant Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactIan Thompson
CorrespondentIan Thompson
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
510k Review PanelImmunology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-01-15

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.