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 |