FDA 510(k)

Wondfo One Step Fecal Occult Blood (FOB) Test

Número K: K162333 · 2017-05-14

RequerenteGuangzhou Wondfo Biotech Co., Ltd.

Data da decisão2017-05-14

Código do produtoKHE

Comité consultivoHE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wondfo One Step Fecal Occult Blood (FOB) Test is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-05-14 under 510(k) number K162333. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wondfo One Step Fecal Occult Blood (FOB) Test?

Wondfo One Step Fecal Occult Blood (FOB) Test is a medical device that received FDA 510(k) clearance on 2017-05-14. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K162333.

When did Wondfo One Step Fecal Occult Blood (FOB) Test receive FDA 510(k) clearance?

Wondfo One Step Fecal Occult Blood (FOB) Test received FDA 510(k) clearance on 2017-05-14, under 510(k) number K162333.

Who is the listed applicant for Wondfo One Step Fecal Occult Blood (FOB) Test?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wondfo One Step Fecal Occult Blood (FOB) Test?

The FDA product code for Wondfo One Step Fecal Occult Blood (FOB) Test is KHE.

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