K250549
- 510(k) number
- K250549
- Device name
- Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit
- Applicant
- The Binding Site Group , Ltd. GB
- Product code
- DFH — Kappa, Antigen, Antiserum, Control
- Decision date
- 2025-05-23
- Date received
- 2025-02-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Immunology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250549.pdf
Official FDA record: K250549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.