K233541
- 510(k) number
- K233541
- Device name
- ARCHITECT Active-B12 (Holotranscobalamin)
- Applicant
- Axis-Shield Diagnostics, Ltd. GB
- Product code
- CDD — Radioassay, Vitamin B12
- Decision date
- 2024-07-31
- Date received
- 2023-11-03
- 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: K233541.pdf
Official FDA record: K233541
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.