FDA 510(k) Application Details - K222379

Device Classification Name	More FDA Info for this Device
510(K) Number	K222379
Device Name	Alinity m STI Assay
Applicant	Abbott Molecular Inc. 1300 E Touhy Ave Des Plaines, IL 60018 US Other 510(k) Applications for this Company
Contact	Paul Matushek Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/2022
Decision Date	03/03/2023
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