FDA 510(k)

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit

Número K: K160819 · 2016-06-16

Data da decisão2016-06-16

Código do produtoOPX

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda 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 2016-06-16 under 510(k) number K160819. The device is classified under product code OPX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit?

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K160819.

When did Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit receive FDA 510(k) clearance?

Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160819.

Who is the listed applicant for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda 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 Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit?

The FDA product code for Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit is OPX.

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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

Ver todos os 17 dispositivos →

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