FDA 510(k)

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS

Número K: K161854 · 2016-10-04

Data da decisão2016-10-04

Código do produtoPCN

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS 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 2016-10-04 under 510(k) number K161854. The device is classified under product code PCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is a medical device that received FDA 510(k) clearance on 2016-10-04. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K161854.

When did Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS receive FDA 510(k) clearance?

Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS received FDA 510(k) clearance on 2016-10-04, under 510(k) number K161854.

Who is the listed applicant for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

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 Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS?

The FDA product code for Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS is PCN.

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Outros registros que listam The Binding Site Group , Ltd. como candidato(a)

K250159Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit K192116Human IgA liquid reagent kit for Use on SPAPlus K191985Optilite IgA Kit K191635Optilite IgM Kit K191465Human IgM Kit for use on SPAPlus

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Dispositivos Relacionados (Código: PCN)

K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group , Ltd.

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