FDA 510(k) Application Details - K221688

Device Classification Name	More FDA Info for this Device
510(K) Number	K221688
Device Name	ASTar BC G- Kit and ASTar Instrument
Applicant	Q-linea AB Dag Hammarskjolds vag 52A Uppsala SE 75237 SE Other 510(k) Applications for this Company
Contact	Jonas Melin 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	06/10/2022
Decision Date	04/26/2024
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