FDA 510(k)

BioTeke® Multi-Drug Urine Test Cup

Número K: K261409 · 2026-09-10

RequerenteBioteke Corporation (Wuxi) Co., Ltd.

Data da decisão2026-09-10

Código do produtoNFT

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioTeke® Multi-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K261409. 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 BioTeke® Multi-Drug Urine Test Cup?

BioTeke® Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K261409.

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

BioTeke® Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2026-09-10, under 510(k) number K261409.

Who is the listed applicant for BioTeke® Multi-Drug Urine Test Cup?

The FDA 510(k) record lists Bioteke Corporation (Wuxi) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTeke® Multi-Drug Urine Test Cup?

The FDA product code for BioTeke® 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 Bioteke Corporation (Wuxi) Co., Ltd. como candidato(a)

K211707BioTeke Sterile Disposable Virus Sampling Kit

Dispositivos Relacionados (Código: NFT)

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

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.