VIDAS NEPHROCHECK

Acute Kidney Injury Test System

BioMérieux SA

The following data is part of a premarket notification filed by Biomérieux Sa with the FDA for Vidas Nephrocheck.

Pre-market Notification Details

Device IDK210793
510k NumberK210793
Device Name:VIDAS NEPHROCHECK
ClassificationAcute Kidney Injury Test System
Applicant bioMérieux SA 376 Chemin De L’Orme Marcy L’Etoile,  FR 69280
ContactJulien Thao My
CorrespondentJulien Thao My
bioMérieux SA 376 Chemin De L’Orme Marcy L’Etoile,  FR 69280
Product CodePIG  
CFR Regulation Number862.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-16
Decision Date2022-07-08

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