FDA 510(k) Application Details - K243202

Device Classification Name	Manual Antimicrobial Susceptibility Test Systems   More FDA Info for this Device
510(K) Number	K243202
Device Name	Manual Antimicrobial Susceptibility Test Systems
Applicant	Liofilchem s. r. l. Via Scozia, Zona Industriale 64026 Roseto degli Abruzzi (TE) IT Other 510(k) Applications for this Company
Contact	Fabio Rocco 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	10/01/2024
Decision Date	01/30/2025
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