FDA 510(k)

Cup de Teste Rápido de Urina de Multi-Drogas AllTest; Cup de Teste de Urina de Multi-Drogas AllTest

Número K: K250727 · 2025-04-04

RequerenteHangzhou AllTest Biotech Co., Ltd.

Data da decisão2025-04-04

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) number K250727. 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 AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K250727.

When did AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup receive FDA 510(k) clearance?

AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-04, under 510(k) number K250727.

Who is the listed applicant for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

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

What is the FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup?

The FDA product code for AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup is NFT.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Hangzhou AllTest Biotech Co., Ltd. como candidato(a)

K260342Teste Rápido de Strep A AllTest K252607Teste de Infeção Urinária AllTest K251053Shinetell PlusTM Digital Early Pregnancy Test K242576Meio de Transporte Viral AllTest K244043AllTest Copo Rápido de Teste de Multi-Drogas; AllTest Copo de Teste de Multi-Drogas K242540Painel de Teste de Urina de Multi-Drogas AllTest; Painel de Teste Rápido de Urina de Multi-Drogas AllTest

Ver todos os 14 dispositivos →

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.