FDA 510(k)

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay

Número K: K181329 · 2018-06-25

Data da decisão2018-06-25

Código do produtoMSV

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA 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 2018-06-25 under 510(k) number K181329. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is a medical device that received FDA 510(k) clearance on 2018-06-25. The listed applicant is Phadia AB. The 510(k) number is K181329.

When did EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay receive FDA 510(k) clearance?

EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay received FDA 510(k) clearance on 2018-06-25, under 510(k) number K181329.

Who is the listed applicant for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA 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 B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?

The FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is MSV.

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Outros registros que listam Phadia AB como candidato(a)

K253367EliA CTD 13 Screen K212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed K210902EliA Ro52, EliA Ro60 K202540EliA Rib-P K202541EliA RNA Pol III K202067EliA SmDP-S

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Fonte oficial

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