Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit

K-Number: K231290 · 2024-01-24

ApplicantThe Binding Site, Ltd.
Decision Date2024-01-24
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit is the device name listed in this FDA 510(k) record. The listed applicant is The Binding Site, Ltd.. It received FDA 510(k) clearance on 2024-01-24 under 510(k) number K231290. 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® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit?

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit is a medical device that received FDA 510(k) clearance on 2024-01-24. The listed applicant is The Binding Site, Ltd.. The 510(k) number is K231290.

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

Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit received FDA 510(k) clearance on 2024-01-24, under 510(k) number K231290.

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

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

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

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

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.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK210623FLC 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.

↑