FDA 510(k) Application Details - K243013

Device Classification Name	More FDA Info for this Device
510(K) Number	K243013
Device Name	LIAISON PLEX Gram-Negative Blood Culture Assay
Applicant	Luminex Corporation 4088 Commercial Ave. Northbrook, IL 60062 US Other 510(k) Applications for this Company
Contact	Sheri Calderon Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2024
Decision Date	04/18/2025
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