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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 a medical device manufactured by The Binding Site Group , Ltd.. It received FDA 510(k) clearance on 2025-05-23 under approval 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. It is manufactured by The Binding Site Group , Ltd.. The 510(k) number is K250549.

When was Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit approved by the FDA?

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

What company makes 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 manufactured by The Binding Site Group , Ltd..

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 Devices by The Binding Site Group , Ltd.

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Related Devices (Code: DFH)

K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain CalibratorDiazyme Laboratories K171742N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2Siemens Healthcare Diagnostics Products GmbH K182098N Latex FLC kappa assay, N Latex FLC lambda assaySiemens Healthcare Diagnostics Products GmbH K173732Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free KitThe Binding Site Group , Ltd. K181438Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc. K190879N Latex FLC kappa, N Latex FLC lambdaSiemens Healthcare Diagnostics Products GmbH

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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