FDA 510(k) Application Details - K232761

Device Classification Name	More FDA Info for this Device
510(K) Number	K232761
Device Name	ProNephro AKIÖ (NGAL)
Applicant	BioPorto Diagnostic Inc. 117 Fourth Avenue Suite 202 Needham, MA 02494 US Other 510(k) Applications for this Company
Contact	Asger Dahlgaard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/08/2023
Decision Date	12/07/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review