The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24 Hours Susceptibility Plates.
| Device ID | K033522 |
| 510k Number | K033522 |
| Device Name: | SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cindy Knapp |
| Correspondent | Cindy Knapp TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-07 |
| Decision Date | 2004-02-03 |