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FDA 510(k)

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit

K-Number: K250549 · 2025-05-23

ApplicantThe Binding Site Group , Ltd.
Decision Date2025-05-23
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K250549. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit?

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K250549.

When did Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit receive FDA 510(k) clearance?

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit received FDA 510(k) clearance on 2025-05-23, under 510(k) number K250549.

Who is the listed applicant for Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit?

The FDA 510(k) record lists The Binding Site Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit?

The FDA product code for Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit is DFH.

Other records listing The Binding Site Group , Ltd. as applicant

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Related Devices (Code: DFH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.K220001Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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