FDA 510(k) Application Details - K193490

Device Classification Name	Reagents, Clostridium Difficile Toxin   More FDA Info for this Device
510(K) Number	K193490
Device Name	Reagents, Clostridium Difficile Toxin
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	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LLH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2019
Decision Date	07/08/2021
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