FDA 510(k) Application Details - K250398

Device Classification Name	More FDA Info for this Device
510(K) Number	K250398
Device Name	Innovita Flu A/B Antigen Rapid Test
Applicant	Innovita (Tangshan) Biological Technology CO., LTD 699 Juxin Street Qian'an 064400 CN Other 510(k) Applications for this Company
Contact	Yan Hua Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2025
Decision Date	07/03/2025
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