FDA 510(k)

Wondfo T-Cup Multi-Drug Urine Test Cup

Número K: K182701 · 2018-12-03

RequerenteGuangzhou Wondfo Biotech Co., Ltd.

Data da decisão2018-12-03

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wondfo T-Cup Multi-Drug Urine Test Cup 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 2018-12-03 under 510(k) number K182701. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wondfo T-Cup Multi-Drug Urine Test Cup?

Wondfo T-Cup Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2018-12-03. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K182701.

When did Wondfo T-Cup Multi-Drug Urine Test Cup receive FDA 510(k) clearance?

Wondfo T-Cup Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2018-12-03, under 510(k) number K182701.

Who is the listed applicant for Wondfo T-Cup Multi-Drug Urine Test Cup?

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 T-Cup Multi-Drug Urine Test Cup?

The FDA product code for Wondfo T-Cup Multi-Drug Urine Test Cup is NFT.

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Outros registros que listam Guangzhou Wondfo Biotech Co., Ltd. como candidato(a)

K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx K251289WELLlife COVID-19 Antigen Test Rx K241317Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx

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Dispositivos Relacionados (Código: NFT)

K261409BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd.K261984AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelVivachek Biotech (Hangzhou) Co., Ltd.K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxGuangzhou Wondfo Biotech Co., Ltd.K260355Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupWEBEST Biotech,, LLC K252550SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxGuangzhou Wondfo Biotech Co., Ltd.

Fonte oficial

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