FDA 510(k) Application Details - K233842

Device Classification Name	More FDA Info for this Device
510(K) Number	K233842
Device Name	iHealth COVID-19 Antigen Rapid Test
Applicant	iHealth Labs, Inc 880 W Maude Ave Sunnyvale, CA 94085 US Other 510(k) Applications for this Company
Contact	Tianyang Liu 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	12/04/2023
Decision Date	05/31/2024
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