FDA 510(k) Application Details - K232545

Device Classification Name	More FDA Info for this Device
510(K) Number	K232545
Device Name	The SensiTox B. anthracis Toxin Test
Applicant	First Light Diagnostics, Inc. 2 Omni Way Chelmsford, MA 01824 US Other 510(k) Applications for this Company
Contact	Joanne Spadoro Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QUU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2023
Decision Date	11/20/2023
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