FDA 510(k) Application Details - K230675

Device Classification Name	More FDA Info for this Device
510(K) Number	K230675
Device Name	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
Applicant	Specific Diagnostics, LLC 130 Baytech Drive San Jose, CA 95134 US Other 510(k) Applications for this Company
Contact	Jolyn Tenllado Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/2023
Decision Date	06/20/2024
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