FDA 510(k)

Optilite IgM CSF Kit

Número K: K190686 · 2019-05-28

Data da decisão2019-05-28

Código do produtoCFN

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Optilite IgM CSF 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 2019-05-28 under 510(k) number K190686. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Optilite IgM CSF Kit?

Optilite IgM CSF Kit is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is The Binding Site Group , Ltd.. The 510(k) number is K190686.

When did Optilite IgM CSF Kit receive FDA 510(k) clearance?

Optilite IgM CSF Kit received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190686.

Who is the listed applicant for Optilite IgM CSF 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 IgM CSF Kit?

The FDA product code for Optilite IgM CSF Kit is CFN.

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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: CFN)

K233663N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)Siemens Healthcare Diagnostics Products GmbH K221114Immunoglobulin G (IgG)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.K192116Human IgA liquid reagent kit for Use on SPAPlusThe Binding Site Group , Ltd.K191985Optilite IgA KitThe Binding Site Group , Ltd.K191635Optilite IgM KitThe Binding Site Group , Ltd.K191465Human IgM Kit for use on SPAPlusThe Binding Site Group , Ltd.

Fonte oficial

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