FDA.reportPublic FDA data

HemoSonics, LLC (SC)

Matched from indexed company URL: Hemosonics, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30142401983014240198HemoSonics, LLC (SC)1N2026-01-014020 Stirrup Creek Drive Suite 105 Durham NC US 27703

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850003761183QStat Cartridge - For Use with the QUANTRA® Hemostasis Analyzer+1(800)280-5589support@hemosonics.com
00850003761336Qstat Control Level 1 - For Use with the QUANTRA® Hemostasis Analyzer+1(800)280-5589support@hemosonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2196651692602661K213917QStat CartridgeQFR2022-11-29
2196652023568593K201513Quantra QPlus SystemQFR2020-08-21
2196651690972164DEN180017Quantra Hemostasis Analyzer, QPlus CartridgeQFR2019-03-12
2196651661531798

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QFR42022-11-29

PMN#

GUDID#