K191499 is an FDA 510(k) clearance for the MAGLUMI 2000 25-OH Vitamin D. 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 August 1, 2019, 56 days after receiving the submission on June 6, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1825.
| 510(k) Number | K191499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2019 |
| Decision Date | August 01, 2019 |
| Days to Decision | 56 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 |