FDA 510(k) Application Details - K250885

Device Classification Name	Susceptibility Test Discs, Antimicrobial   More FDA Info for this Device
510(K) Number	K250885
Device Name	Susceptibility Test Discs, Antimicrobial
Applicant	Liofilchem Inc. 465 Waverley Oakes Road Suite 317 Waltham, MA 02452 US Other 510(k) Applications for this Company
Contact	Emily Hodgkins Other 510(k) Applications for this Contact
Regulation Number	866.1620   More FDA Info for this Regulation Number
Classification Product Code	JTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2025
Decision Date	06/23/2025
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