FDA 510(k)

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

Número K: K173792 · 2018-03-13

Data da decisão2018-03-13

Código do produtoMOB

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-03-13 under 510(k) number K173792. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Phadia AB. The 510(k) number is K173792.

When did EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay receive FDA 510(k) clearance?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay received FDA 510(k) clearance on 2018-03-13, under 510(k) number K173792.

Who is the listed applicant for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

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

What is the FDA product code for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

The FDA product code for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is MOB.

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Outros registros que listam Phadia AB como candidato(a)

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