FDA 510(k)

Allerhope Allergy Skin Tester

Número K: K162917 · 2017-08-17

RequerenteProcare Industrial Co., Limited

Data da decisão2017-08-17

Código do produtoSCL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Allerhope Allergy Skin Tester is the device name listed in this FDA 510(k) record. The listed applicant is Procare Industrial Co., Limited. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K162917. 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 Allerhope Allergy Skin Tester?

Allerhope Allergy Skin Tester is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Procare Industrial Co., Limited. The 510(k) number is K162917.

When did Allerhope Allergy Skin Tester receive FDA 510(k) clearance?

Allerhope Allergy Skin Tester received FDA 510(k) clearance on 2017-08-17, under 510(k) number K162917.

Who is the listed applicant for Allerhope Allergy Skin Tester?

The FDA 510(k) record lists Procare Industrial Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allerhope Allergy Skin Tester?

The FDA product code for Allerhope Allergy Skin Tester is SCL.

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