The following data is part of a premarket notification filed by Liposcience with the FDA for Vantera Clinical Analyzer.
| Device ID | K133849 |
| 510k Number | K133849 |
| Device Name: | VANTERA CLINICAL ANALYZER |
| Classification | Instrumentation For Clinical Multiplex Test Systems |
| Applicant | LIPOSCIENCE 2500 SUMMER BLVD. Raleigh, NC 27616 |
| Contact | Suzette Warner |
| Correspondent | Suzette Warner LIPOSCIENCE 2500 SUMMER BLVD. Raleigh, NC 27616 |
| Product Code | NSU |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| Subsequent Product Code | MRR |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-19 |
| Decision Date | 2014-10-22 |
| Summary: | summary |