FDA 510(k) Application Details - K241652

Device Classification Name	More FDA Info for this Device
510(K) Number	K241652
Device Name	DASH« SARS-CoV-2 & Flu A/B Test
Applicant	Nuclein, LLC 8305 Cross Park Dr. Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Ben Treece Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2024
Decision Date	12/20/2024
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