The following data is part of a premarket notification filed by Liposcience with the FDA for Vantera Clinical Analyzer.
| Device ID | K113830 |
| 510k Number | K113830 |
| Device Name: | VANTERA CLINICAL ANALYZER |
| Classification | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Applicant | LIPOSCIENCE 2500 SUMMER BLVD. Raleigh, NC 27616 |
| Contact | Suzette Warner |
| Correspondent | Suzette Warner LIPOSCIENCE 2500 SUMMER BLVD. Raleigh, NC 27616 |
| Product Code | CDT |
| Subsequent Product Code | LBS |
| Subsequent Product Code | MRR |
| Subsequent Product Code | NSU |
| CFR Regulation Number | 862.1705 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-27 |
| Decision Date | 2012-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3959930030 | K113830 | 000 |
| B3959920030 | K113830 | 000 |
| B3959910030 | K113830 | 000 |
| B3959900300 | K113830 | 000 |