ADVIA Centaur HAV Total Assay

Hepatitis A Test (antibody And Igm Antibody)

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 Hav Total Assay.

Pre-market Notification Details

Device IDK142758
510k NumberK142758
Device Name:ADVIA Centaur HAV Total Assay
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
ContactPhilip Liu
CorrespondentPhilip Liu
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown,  NY  10591
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-25
Decision Date2014-12-05
Summary:summary

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