The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre Yeastone Susceptibility Plates- Additional Antimicrobics.
| Device ID | K081063 |
| 510k Number | K081063 |
| Device Name: | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS |
| Classification | Susceptibility Test Plate, Antifungal |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | NGZ |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2009-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M578YO2IVD2 | K081063 | 000 |
| 05032384511419 | K081063 | 000 |