FDA 510(k) Application Details - K211815

Device Classification Name	More FDA Info for this Device
510(K) Number	K211815
Device Name	LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
Applicant	Affinity Biosensors 222 East Canon Perdido Street Suite 101 Santa Barbara, CA 93101 US Other 510(k) Applications for this Company
Contact	Ken Babcock Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2021
Decision Date	04/02/2024
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