FDA 510(k)

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M

Número K: K193525 · 2020-06-26

Data da decisão2020-06-26

Código do produtoCZP

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K193525. The device is classified under product code CZP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is HORIBA ABX SAS. The 510(k) number is K193525.

When did Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M receive FDA 510(k) clearance?

Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M received FDA 510(k) clearance on 2020-06-26, under 510(k) number K193525.

Who is the listed applicant for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

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

What is the FDA product code for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M?

The FDA product code for Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M is CZP.

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Outros registros que listam HORIBA ABX SAS como candidato(a)

K260781Yumizen H550 K232946Yumizen H2500 K193649Yumizen C1200 Creatinine PAP K192028Yumizen C1200 CRP K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor K191993Yumizen C1200 CRP

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