The following data is part of a premarket notification filed by Liposcience, Inc with the FDA for Nmr Lipoprofile (r) Test And Nmr Profiler.
| Device ID | K111516 |
| 510k Number | K111516 |
| Device Name: | NMR LIPOPROFILE (R) TEST AND NMR PROFILER |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | LIPOSCIENCE, INC 2500 Sumner Blvd Raleigh, NC 27616 |
| Contact | Suzette M Warner |
| Correspondent | Suzette M Warner LIPOSCIENCE, INC 2500 Sumner Blvd Raleigh, NC 27616 |
| Product Code | LBS |
| Subsequent Product Code | CDT |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-09-27 |
| Summary: | summary |