FDA 510(k) Application Details - DEN180017

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180017
Device Name	Quantra Hemostasis Analyzer, QPlus Cartridge
Applicant	HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville, VA 22903 US Other 510(k) Applications for this Company
Contact	Anne Zavertnik 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	04/02/2018
Decision Date	03/12/2019
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review