K232587 is an FDA 510(k) clearance for the MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer. This device is classified as a System, Test, Vitamin D (Class II - Special Controls, product code MRG).
Submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 12, 2024, 231 days after receiving the submission on August 25, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K232587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2023 |
| Decision Date | April 12, 2024 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MRG - System, Test, Vitamin D |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1825 |