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 | K160372 |
| 510k Number | K160372 |
| Device Name: | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Aquil Merchant |
| Correspondent | Aquil Merchant TECO DIAGNOSTICS, INC. 1268 N. LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JIL |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JIO |
| Subsequent Product Code | JIR |
| Subsequent Product Code | JJB |
| Subsequent Product Code | JMT |
| Subsequent Product Code | JRE |
| Subsequent Product Code | KQO |
| Subsequent Product Code | LJX |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-10 |
| Decision Date | 2016-07-22 |
| Summary: | summary |