FDA 510(k) Application Details - K240728

Device Classification Name	More FDA Info for this Device
510(K) Number	K240728
Device Name	CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
Applicant	CorDx, Inc. 9540 Waples St. # C San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Haixia Yang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2024
Decision Date	06/21/2024
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