The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urs-ig (glucose Test).
| Device ID | K020175 |
| 510k Number | K020175 |
| Device Name: | URS-IG (GLUCOSE TEST) |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Olivia Chen |
| Correspondent | Olivia Chen TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-17 |
| Decision Date | 2002-03-21 |