The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Uritek 151 Urine Analyzer, Model Tc-151.
| Device ID | K042421 |
| 510k Number | K042421 |
| Device Name: | URITEK 151 URINE ANALYZER, MODEL TC-151 |
| Classification | Automated Urinalysis System |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Tong S Chiah |
| Correspondent | Tong S Chiah TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | KQO |
| Subsequent Product Code | CDM |
| Subsequent Product Code | CEN |
| Subsequent Product Code | JIL |
| 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 | LJX |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2005-05-09 |