The following data is part of a premarket notification filed by Liposcience with the FDA for Nmr Profiler And Nmr Lipoprofile Assay, Controls.
| Device ID | K063841 |
| 510k Number | K063841 |
| Device Name: | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | LIPOSCIENCE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Mark A Del Vecchio |
| Correspondent | Mark A Del Vecchio LIPOSCIENCE 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Product Code | MRR |
| Subsequent Product Code | CDT |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| Subsequent Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2008-07-23 |
| Summary: | summary |