FDA 510(k)

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx

N.º K: K252550 · 2025-11-18

SolicitanteGuangzhou Wondfo Biotech Co., Ltd.

Fecha de decisión2025-11-18

Código de productoNFT

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 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 2025-11-18 under 510(k) number K252550. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K252550.

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

SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252550.

Who is the listed applicant for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

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 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx?

The FDA product code for SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx is NFT.

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Otros registros que enlistan a Guangzhou Wondfo Biotech Co., Ltd. como solicitante

K260065SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel 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 K182701Wondfo T-Cup Multi-Drug Urine Test Cup

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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 K252867VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupAdvin Biotech, Inc.

Fuente oficial

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