FDA 510(k) Application Details - K232967

Device Classification Name	Susceptibility Test Plate, Antifungal   More FDA Info for this Device
510(K) Number	K232967
Device Name	Susceptibility Test Plate, Antifungal
Applicant	bioMerieux, Inc. 595 Anglum Rd. Hazelwood, MO 63042 US Other 510(k) Applications for this Company
Contact	Esther Hernandez Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/21/2023
Decision Date	06/12/2024
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