The following data is part of a premarket notification filed by Trek Diagnostic Systems, Inc. with the FDA for Sensititre 18-24 Hour Susceptibility Plate.
| Device ID | K031545 |
| 510k Number | K031545 |
| Device Name: | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| 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 | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M578ESB1F2 | K031545 | 000 |