MRG

System, Test, Vitamin D

Product code
MRG
Device name
System, Test, Vitamin D
Device class
Class 2
21 CFR
21 CFR 862.1825
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
46 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-04-12.

NumberDecision dateApplicantDevice nameSummary
K2325872024-04-12Shenzhen New Industries Biomedical EngMAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiPDF
K2218172023-09-22Immunostics Inc.,ALFIS Vitamin D, ALFIS-3 AnalyzerPDF

2 summaries are archived here for direct download.

Official FDA classification page: MRG
Classification and pathway per current FDA publications. Data from openFDA (CC0).