FDA 510(k) Application Details - K211748

Device Classification Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation   More FDA Info for this Device
510(K) Number	K211748
Device Name	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
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	866.1645   More FDA Info for this Regulation Number
Classification Product Code	LON Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2021
Decision Date	04/19/2023
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