FDA 510(k) Application Details - K243405

Device Classification Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species   More FDA Info for this Device
510(K) Number	K243405
Device Name	System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Applicant	Cepheid« 904 Caribbean Drive Sunnyvale, CA 94089 US Other 510(k) Applications for this Company
Contact	Suzette Chance Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	NIJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/2024
Decision Date	11/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review