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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 K232761
Device Name ProNephro AKI™ (NGAL)
Applicant
Bioporto Diagnostic, Inc.
117 Fourth Ave. Suite 202
Needham,  MA  02494
Applicant Contact Asger Dahlgaard
Correspondent
Bioporto Diagnostics A/S
Tuborg Havnevej 15, St.
Hellerup,  DK 2900
Correspondent Contact Monika Bak
Regulation Number862.1220
Classification Product Code
PIG  
Date Received09/08/2023
Decision Date 12/07/2023
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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