ADVIA Centaur® Digoxin Assay

Enzyme Immunoassay, Digoxin

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® Digoxin Assay.

Pre-market Notification Details

Device IDK193397
510k NumberK193397
Device Name:ADVIA Centaur® Digoxin Assay
ClassificationEnzyme Immunoassay, Digoxin
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 CodeKXT  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-06
Decision Date2021-07-16

Trademark Results [ADVIA Centaur]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADVIA CENTAUR
ADVIA CENTAUR
75658644 2427460 Live/Registered
SIEMENS HEALTHCARE DIAGNOSTICS INC.
1999-03-11

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