The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Scanostics Uti Check Application Test System.
| Device ID | K170118 |
| 510k Number | K170118 |
| Device Name: | Scanostics UTI Check Application Test System |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | Teco Diagnostics 1268 N Lakeview Ave Anaheim, CA 92807 |
| Contact | Ling Koh |
| Correspondent | Ling Koh Teco Diagnostics 1268 N Lakeview Ave Anaheim, CA 92807 |
| Product Code | JMT |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-13 |
| Decision Date | 2017-09-21 |
| Summary: | summary |