The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Direct Hdl Cholesterol And Direct Hdl/ldl Calibrator.
| Device ID | K050823 |
| 510k Number | K050823 |
| Device Name: | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR |
| Classification | Ldl & Vldl Precipitation, Hdl |
| 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 | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-31 |
| Decision Date | 2005-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001891 | K050823 | 000 |
| 10673486001907 | K050823 | 000 |