ADVIA Centaur CA 15-3 Assay

System, Test, Immunological, Antigen, Tumor

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 Ca 15-3 Assay.

Pre-market Notification Details

Device IDK192777
501k NumberK192777
Device Name:ADVIA Centaur CA 15-3 Assay
ClassificationSystem, Test, Immunological, Antigen, Tumor
Applicant Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown,  NY  10591
ContactAnoop Joy
CorrespondentAnoop Joy
Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue Tarrytown,  NY  10591
Product CodeMOI  
CFR Regulation Number866.6010 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
501k Review PanelImmunology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2019-11-22

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