FDA 510(k) Application Details - K242659

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K242659
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	Thermofisher Scientific 1 Thermofisher Way Oakwood Village, OH 44146 US Other 510(k) Applications for this Company
Contact	Joel Mathew 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	09/04/2024
Decision Date	05/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review