Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

Iga, Antigen, Antiserum, Control

Horiba ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M.

Pre-market Notification Details

Device IDK193525
510k NumberK193525
Device Name:Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
ClassificationIga, Antigen, Antiserum, Control
Applicant Horiba ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4,  FR 341184
ContactCaroline Ferrer
CorrespondentCaroline Ferrer
Horiba ABX SAS Parc Euromedecine, Rue Du Caducee BP7290 Montpellier Cedex 4,  FR 341184
Product CodeCZP  
Subsequent Product CodeCFN
Subsequent Product CodeDEW
Subsequent Product CodeDFT
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-06-26

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