FDA 510(k)

Oryum and Ovem Epidermal Deri Prick Test Applicator

Número K: K182582 · 2019-04-10

RequerenteAllergy & Applicator Depot, LLC

Data da decisão2019-04-10

Código do produtoSCL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Oryum and Ovem Epidermal Deri Prick Test Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Allergy & Applicator Depot, LLC. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K182582. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Oryum and Ovem Epidermal Deri Prick Test Applicator?

Oryum and Ovem Epidermal Deri Prick Test Applicator is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Allergy & Applicator Depot, LLC. The 510(k) number is K182582.

When did Oryum and Ovem Epidermal Deri Prick Test Applicator receive FDA 510(k) clearance?

Oryum and Ovem Epidermal Deri Prick Test Applicator received FDA 510(k) clearance on 2019-04-10, under 510(k) number K182582.

Who is the listed applicant for Oryum and Ovem Epidermal Deri Prick Test Applicator?

The FDA 510(k) record lists Allergy & Applicator Depot, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator?

The FDA product code for Oryum and Ovem Epidermal Deri Prick Test Applicator is SCL.

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