FDA 510(k) Application Details - K233358

Device Classification Name	More FDA Info for this Device
510(K) Number	K233358
Device Name	SCoV-2 Ag Detect Rapid Test
Applicant	InBios International, Inc. 307 Westlake Ave N, Suite 300 Seattle, WA 98109 US Other 510(k) Applications for this Company
Contact	Annabel Tsai Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QVF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	08/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Dual Track
Reviewed By Third Party	N
Expedited Review