The following data is part of a premarket notification filed by Trek Diagnostic Systems, Ltd. with the FDA for Sensititre Aim (tm).
| Device ID | K110331 |
| 510k Number | K110331 |
| Device Name: | SENSITITRE AIM (TM) |
| Classification | Reagent/device, Inoculum Calibration |
| Applicant | TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | LIE |
| Subsequent Product Code | JWY |
| Subsequent Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-03 |
| Decision Date | 2011-04-27 |