Yumizen C1200 CRP

C-reactive Protein, Antigen, Antiserum, And Control

Horiba ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Crp.

Pre-market Notification Details

Device IDK192028
510k NumberK192028
Device Name:Yumizen C1200 CRP
ClassificationC-reactive Protein, Antigen, Antiserum, And 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 CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-26
Decision Date2020-06-25

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