Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

Ferritin, 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 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor.

Pre-market Notification Details

Device IDK191562
510k NumberK191562
Device Name:Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
ClassificationFerritin, 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 CodeDBF  
Subsequent Product CodeDDG
Subsequent Product CodeDHR
CFR Regulation Number866.5340 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
510k Review PanelImmunology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-13
Decision Date2020-03-06

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