The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Ise Reagent Set For Cx System.
| Device ID | K052724 |
| 510k Number | K052724 |
| Device Name: | TECO ISE REAGENT SET FOR CX SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| 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 | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | LIX |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-12-14 |