The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Homocysteine Enzymatic Assay.
| Device ID | K063701 |
| 510k Number | K063701 |
| Device Name: | TECO HOMOCYSTEINE ENZYMATIC ASSAY |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| 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 | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-04-11 |