The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Direct Ldl Cholesterol, Model L530-60h.
| Device ID | K051121 |
| 510k Number | K051121 |
| Device Name: | DIRECT LDL CHOLESTEROL, MODEL L530-60H |
| Classification | System, Test, Low Density, Lipoprotein |
| 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 | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-02 |
| Decision Date | 2005-08-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002010 | K051121 | 000 |