FDA 510(k)

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite

Número K: K150597 · 2016-02-29

Data da decisão2016-02-29

Código do produtoDHB

Comité consultivoIM

DecisãoSubstantially Equivalent

Resumo do dispositivo

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-02-29 under 510(k) number K150597. 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 d202, Allergen component rDer p 1,House dust mite?

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is a medical device that received FDA 510(k) clearance on 2016-02-29. The listed applicant is Phadia AB. The 510(k) number is K150597.

When did ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite receive FDA 510(k) clearance?

ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite received FDA 510(k) clearance on 2016-02-29, under 510(k) number K150597.

Who is the listed applicant for ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite?

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 d202, Allergen component rDer p 1,House dust mite?

The FDA product code for ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite is DHB.

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Fonte oficial

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