FDA 510(k) Application Details - K223093

Device Classification Name	System, Test, Anticardiolipin Immunological   More FDA Info for this Device
510(K) Number	K223093
Device Name	System, Test, Anticardiolipin Immunological
Applicant	INOVA Diagnostics, Inc. 9900 Old Grove Road San Diego, CA 92131 US Other 510(k) Applications for this Company
Contact	Andrea Seaman Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	MID Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	12/17/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review