MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer— 510(k) K232587
Substantially EquivalentShenzhen New Industries Biomedical Engineering Co., Ltd.
FDA 510(k) clearance K232587 for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer, Substantially Equivalent on 2024-04-12. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd..
Clearance details
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Product code
- Code MRG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Data sourced from openFDA. This site is unofficial and independent of the FDA.