FDA 510(k) Application Details - K231758

Device Classification Name	More FDA Info for this Device
510(K) Number	K231758
Device Name	NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
Applicant	Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	Kate Goscha Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/16/2023
Decision Date	03/11/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review