The following data is part of a premarket notification filed by Teco Diagnostics, Inc. with the FDA for Uritek Tc-201 Urine Chemistry Test System.
| Device ID | K152835 |
| 510k Number | K152835 |
| Device Name: | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
| Classification | Enzymatic Method, Creatinine |
| Applicant | TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Yunyuan Vivian Wang |
| Correspondent | Yunyuan Vivian Wang TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JFY |
| Subsequent Product Code | JIR |
| Subsequent Product Code | KQO |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-03-07 |
| Summary: | summary |