K221817
- 510(k) number
- K221817
- Device name
- ALFIS Vitamin D, ALFIS-3 Analyzer
- Applicant
- Immunostics Inc., NJ · US
- Product code
- MRG — System, Test, Vitamin D
- Decision date
- 2023-09-22
- Date received
- 2022-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K221817.pdf
Official FDA record: K221817
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.