The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24hr Susceptibility Plates.
| Device ID | K093865 |
| 510k Number | K093865 |
| Device Name: | SENSITITRE 18-24HR SUSCEPTIBILITY PLATES |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Contact | Cindy Knapp |
| Correspondent | Cindy Knapp TREK DIAGNOSTIC SYSTEMS, INC. 982 KEYNOTE CIRCLE 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 | 2009-12-16 |
| Decision Date | 2010-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M578FDANDSF2 | K093865 | 000 |
| 05032384497546 | K093865 | 000 |