FDA 510(k)

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

Número K: K200279 · 2020-05-01

Data da decisão2020-05-01

Código do produtoDHB

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K200279. The device is classified under product code DHB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine?

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Phadia AB. The 510(k) number is K200279.

When did ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine receive FDA 510(k) clearance?

ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200279.

Who is the listed applicant for ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine?

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 ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine?

The FDA product code for ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine is DHB.

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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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