Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit— 510(k) K250549

Substantially Equivalent

The 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..

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DFH
Advisory panel: Immunology
Date received: 2025-02-25
Decision date: 2025-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

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