FDA 510(k) Application Details - K244044

Device Classification Name	More FDA Info for this Device
510(K) Number	K244044
Device Name	PBC Separator with Selux AST System
Applicant	Selux Diagnostics, Inc. 56 Roland Street, Suite 206 Charlestown, MA 02129 US Other 510(k) Applications for this Company
Contact	Carrene Plummer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2024
Decision Date	03/28/2025
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