The following data is part of a De Novo classification by Hemosonics, Llc with the FDA for Quantra Hemostasis Analyzer, Qplus Cartridge.
| DeNovo ID | DEN180017 |
| Device Name: | Quantra Hemostasis Analyzer, QPlus Cartridge |
| Classification | Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties |
| Applicant | HemoSonics, LLC 400 Preston Avenue, Suite 250 Charlottesville, VA 22903 |
| Contact | Anne Zavertnik |
| Product Code | QFR |
| CFR Regulation Number | 864.5430 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Hematology |
| Classification Advisory | Hematology |
| Type | Direct |
| Date Received | 2018-04-02 |
| Decision Date | 2019-03-12 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850003761081 | DEN180017 | 000 |
| 10850003761074 | DEN180017 | 000 |
| 10850003761067 | DEN180017 | 000 |
| 00850003761039 | DEN180017 | 000 |
| 00850003761046 | DEN180017 | 000 |
| 00850003761275 | DEN180017 | 000 |
| 00850003761213 | DEN180017 | 000 |
| 00850003761107 | DEN180017 | 000 |