FDA 510(k)

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

Numéro K : K250549 · 2025-05-23

Date de décision2025-05-23

Code produitDFH

Comité consultatifIM

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant The Binding Site Group , Ltd. en tant que demandeur

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Dispositifs connexes (Code : DFH)

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 2Sebia K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2Sebia K211648Diazyme 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.

Source officielle

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