FDA 510(k) Application Details - K240045

Device Classification Name	More FDA Info for this Device
510(K) Number	K240045
Device Name	QStat Cartridge
Applicant	HemoSonics LLC 4020 Stirrup Creek Drive Suite 105 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Deborah Winegar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2024
Decision Date	03/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review