Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit— 510(k) K250549
Substantially EquivalentThe Binding Site Group , Ltd.
FDA 510(k) clearance K250549 for Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit, Substantially Equivalent on 2025-05-23. Applicant: The Binding Site Group , Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site Group , Ltd.
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, GB
Recent devices under product code DFH
view all- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2
- K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
- K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
- K211648 — Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
More clearances from The Binding Site Group , Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.