FDA 510(k) Application Details - K223493

Device Classification Name	More FDA Info for this Device
510(K) Number	K223493
Device Name	PBC Separator with Selux AST System
Applicant	Selux Diagnostics, Inc 56 Roland St, Suite 206 Charlestown, MA 02129 US Other 510(k) Applications for this Company
Contact	Eric Stern 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	11/21/2022
Decision Date	02/15/2024
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