FDA 510(k)

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2

Número K: K231601 · 2024-02-23

RequerenteSebia

Data da decisão2024-02-23

Código do produtoDFH

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2024-02-23 under 510(k) number K231601. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is a medical device that received FDA 510(k) clearance on 2024-02-23. The listed applicant is Sebia. The 510(k) number is K231601.

When did FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 receive FDA 510(k) clearance?

FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 received FDA 510(k) clearance on 2024-02-23, under 510(k) number K231601.

Who is the listed applicant for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

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

What is the FDA product code for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2?

The FDA product code for FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 is DFH.

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Dispositivos Relacionados (Código: DFH)

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.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.

Fonte oficial

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