FDA 510(k) Application Details - K242613

Device Classification Name	Respiratory Virus Panel Nucleic Acid Assay System   More FDA Info for this Device
510(K) Number	K242613
Device Name	Respiratory Virus Panel Nucleic Acid Assay System
Applicant	Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto M5G 1Y8 CA Other 510(k) Applications for this Company
Contact	Tara Vivian Other 510(k) Applications for this Contact
Regulation Number	866.3980   More FDA Info for this Regulation Number
Classification Product Code	OCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2024
Decision Date	10/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review