HemoSonics, LLC (SC)
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014240198 | 3014240198 | HemoSonics, LLC (SC) | 1 | N | 2026-01-01 | 4020 Stirrup Creek Drive Suite 105 Durham NC US 27703 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 219665 | 1692602661 | K213917 | QStat Cartridge | QFR | 2022-11-29 |
| 219665 | 2023568593 | K201513 | Quantra QPlus System | QFR | 2020-08-21 |
| 219665 | 1690972164 | DEN180017 | Quantra Hemostasis Analyzer, QPlus Cartridge | QFR | 2019-03-12 |
| 219665 | 1661531798 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QFR | 4 | 2022-11-29 |