FDA 510(k) Application Details - K230461

Device Classification Name	More FDA Info for this Device
510(K) Number	K230461
Device Name	Quantra Hemostasis Analyzer
Applicant	HemoSonics, LLC 4020 Stirrup Creek Drive, Suite 105 Durham, NC 27703 US Other 510(k) Applications for this Company
Contact	Debbie 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	02/21/2023
Decision Date	03/24/2023
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