FDA 510(k)

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

Número K: K252259 · 2025-08-15

Data da decisão2025-08-15

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2025-08-15 under 510(k) number K252259. 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 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-08-15. The listed applicant is Assure Tech., LLC. The 510(k) number is K252259.

When did AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup receive FDA 510(k) clearance?

AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup received FDA 510(k) clearance on 2025-08-15, under 510(k) number K252259.

Who is the listed applicant for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

The FDA 510(k) record lists Assure Tech., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup?

The FDA product code for AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup is NFT.

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Outros registros que listam Assure Tech., LLC como candidato(a)

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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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