The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Cx3 Reagent Set For Synchron Cx System.
| Device ID | K060120 |
| 510k Number | K060120 |
| Device Name: | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Jian Vaeches |
| Correspondent | Jian Vaeches TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | CDQ |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CIC |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-17 |
| Decision Date | 2006-03-27 |
| Summary: | summary |