The following data is part of a premarket notification filed by Trek Diagnostic Systems with the FDA for The Sensititre Aim.
| Device ID | K103456 |
| 510k Number | K103456 |
| Device Name: | THE SENSITITRE AIM |
| Classification | Reagent/device, Inoculum Calibration |
| Applicant | TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS 982 KEYNOTE CIRCLE 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 | 2010-11-24 |
| Decision Date | 2011-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838097409 | K103456 | 000 |
| 05032384497409 | K103456 | 000 |