FDA 510(k) Application Details - K250856

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K250856
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	bioMΘrieux 376 chemin de l'Orme Marcy-l'Etoile 69280 FR Other 510(k) Applications for this Company
Contact	StΘphanie Millon-Serme Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	JWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/21/2025
Decision Date	06/12/2025
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