The following data is part of a premarket notification filed by Trek Diagnostic Systems with the FDA for Sensititre Yeastone Susceptibility Plates.
| Device ID | K133038 |
| 510k Number | K133038 |
| Device Name: | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | TREK DIAGNOSTIC SYSTEMS 1 Thermo Fisher Way Oakwood Village, OH 44146 |
| Contact | Cindy Knapp |
| Correspondent | Cindy Knapp TREK DIAGNOSTIC SYSTEMS 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 | 2013-09-26 |
| Decision Date | 2014-01-31 |