The following data is part of a De Novo classification by Leica Microsystems (schweiz) Ag with the FDA for Leica Fl400.
| DeNovo ID | DEN180024 |
| Device Name: | Leica FL400 |
| Applicant | Leica Microsystems (Schweiz) AG max Schmidheiny-strasse 201 Heerbrugg, CH 9435 |
| Contact | Grainne Griffin |
| Product Code | QFX |
| Decision | Granted (DENG) |
| Review Advisory Board | Neurology |
| Type | Direct |
| Date Received | 2018-04-27 |
| Decision Date | 2019-03-28 |