FDA 510(k) Application Details - K243561

Device Classification Name	More FDA Info for this Device
510(K) Number	K243561
Device Name	Nano-Check Influenza+COVID-19 Dual Test
Applicant	Nano-Ditech Corporation 259 Prospect Plains Rd., Bldg K Cranbury, NJ 08512 US Other 510(k) Applications for this Company
Contact	James B Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	06/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review