510(k) K232587 ยท MRG System, Test, Vitamin D
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
| Applicant | Shenzhen New Industries Biomedical Engineering Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 12, 2024 |
| Received | Aug 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232587
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.