FDA 510(k) Application Details - K241921

Device Classification Name	More FDA Info for this Device
510(K) Number	K241921
Device Name	Alinity m BKV
Applicant	Abbott Molecular Inc. 1300 E Touhy Ave Des Plaines, IL 60018 US Other 510(k) Applications for this Company
Contact	Gina Sammarco Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	03/24/2025
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