FDA 510(k) Application Details - K243485

Device Classification Name	More FDA Info for this Device
510(K) Number	K243485
Device Name	Alinity m CMV
Applicant	Abbott Molecular Inc. 1350 East Touhy Avenue Des Plaines, IL 60018 US Other 510(k) Applications for this Company
Contact	Stacy Ferguson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2024
Decision Date	07/01/2025
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