K231290
- 510(k) number
- K231290
- Device name
- Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- Applicant
- The Binding Site, Ltd. GB
- Product code
- DFH — Kappa, Antigen, Antiserum, Control
- Decision date
- 2024-01-24
- Date received
- 2023-05-04
- 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: K231290.pdf
Official FDA record: K231290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.