K232587
- 510(k) number
- K232587
- Device name
- MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd. CN
- Product code
- MRG — System, Test, Vitamin D
- Decision date
- 2024-04-12
- Date received
- 2023-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232587.pdf
Official FDA record: K232587
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.