Source document or public record
FDA 510(k) K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
FDA 510(k) index record K231290. Device: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit. Applicant as listed: The Binding Site, Ltd.. Decision date: 2024-01-24.
Source
"device_name": "Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K231290.
Device name: Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit. Applicant as listed: The Binding Site, Ltd..
Decision date: 2024-01-24. Decision wording: Substantially Equivalent.
Product code: DFH. Regulation: 21 CFR 866.5550. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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