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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acute Kidney Injury Test System
510(k) Number K210793
Device Name VIDAS NEPHROCHECK
Applicant
Biomérieux SA
376 Chemin De L’Orme
Marcy L'Etoile,  FR 69280
Applicant Contact Julien Thao My
Correspondent
Biomérieux SA
376 Chemin De L’Orme
Marcy L'Etoile,  FR 69280
Correspondent Contact Julien Thao My
Regulation Number862.1220
Classification Product Code
PIG  
Date Received03/16/2021
Decision Date 07/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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