FDA 510(k) Application Details - K233410

Device Classification Name	More FDA Info for this Device
510(K) Number	K233410
Device Name	LIAISON PLEX Respiratory Flex Assay
Applicant	Luminex Corporation 4088 Commercial Avenue Northbrook, IL 60062 US Other 510(k) Applications for this Company
Contact	Tara Viviani 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	10/06/2023
Decision Date	03/01/2024
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