FDA 510(k) Application Details - K250768

Device Classification Name	More FDA Info for this Device
510(K) Number	K250768
Device Name	Elecsys Anti-SARS-CoV-2
Applicant	Roche Diagnostics 9115 Hague Rd Indianapolis, IN 46256 US Other 510(k) Applications for this Company
Contact	Tammy Dean Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2025
Decision Date	06/10/2025
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