Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

Azo Dye, Calcium

Horiba ABX SAS

The following data is part of a premarket notification filed by Horiba Abx Sas with the FDA for Yumizen C1200 Calcium As, Yumizen C1200 Creatinine Jaffe.

Pre-market Notification Details

Device IDK191396
510k NumberK191396
Device Name:Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
ClassificationAzo Dye, Calcium
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 CodeCJY  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-24
Decision Date2019-07-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03610230008607 K191396 000
03610230006955 K191396 000

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