K210801 is an FDA 510(k) clearance for the AXINON® LDL-p Test System. This device is classified as a System, Test, Low Density, Lipoprotein (Class I - General Controls, product code MRR).
Submitted by Numares AG (Regensburg, DE). The FDA issued a Cleared decision on July 19, 2023, 854 days after receiving the submission on March 17, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K210801 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2021 |
| Decision Date | July 19, 2023 |
| Days to Decision | 854 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRR - System, Test, Low Density, Lipoprotein |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |