The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Sensititre Yeastone Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/ml.
| Device ID | K211539 |
| 510k Number | K211539 |
| Device Name: | Sensititre YeastOne Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/mL |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44146 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44146 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-18 |
| Decision Date | 2021-12-15 |