FDA 510(k)

Preview Digital Pregnancy Test

Número K: K173229 · 2018-03-12

RequerenteGuangzhou Wondfo Biotech Co., Ltd.

Data da decisão2018-03-12

Código do produtoLCX

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Preview Digital Pregnancy 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 2018-03-12 under 510(k) number K173229. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Preview Digital Pregnancy Test?

Preview Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K173229.

When did Preview Digital Pregnancy Test receive FDA 510(k) clearance?

Preview Digital Pregnancy Test received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173229.

Who is the listed applicant for Preview Digital Pregnancy 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 Preview Digital Pregnancy Test?

The FDA product code for Preview Digital Pregnancy Test is LCX.

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