Hemosonics, LLC FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Quantra QStat Cartridge510(k)Aug 25, 2025Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Aug 25, 2025
QStat Cartridge510(k)Mar 27, 2024Hematology	Hematology	510(k)Substantially Equivalent (Special)	Mar 27, 2024
Quantra Hemostasis Analyzer510(k)Aug 24, 2023Hematology	Hematology	510(k)Substantially Equivalent (Special)	Aug 24, 2023
Quantra Hemostasis Analyzer510(k)Mar 24, 2023Hematology	Hematology	510(k)Substantially Equivalent (Special)	Mar 24, 2023
Quantra QPlus System510(k)Dec 13, 2022Hematology	Hematology	510(k)Substantially Equivalent (Special)	Dec 13, 2022
QStat Cartridge510(k)Nov 29, 2022Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Nov 29, 2022