The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Tc Matrix Clinical Chemistry Analyzer.
| Device ID | K073370 |
| 510k Number | K073370 |
| Device Name: | TC MATRIX CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Jim Vaechhes |
| Correspondent | Jim Vaechhes TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JJE |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CKA |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-30 |
| Decision Date | 2008-05-08 |