ADVIA Centaur CMV IgG And ADVIA Centaur CMV IgG Quality Control

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

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 Cmv Igg And Advia Centaur Cmv Igg Quality Control.

Pre-market Notification Details

Device IDK181213
510k NumberK181213
Device Name:ADVIA Centaur CMV IgG And ADVIA Centaur CMV IgG Quality Control
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown,  NY  10591
ContactKira Gordon
CorrespondentKira Gordon
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown,  NY  10591
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-07
Decision Date2018-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414246635 K181213 000
00630414246482 K181213 000
00630414588872 K181213 000
00630414587448 K181213 000

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