FDA 510(k)

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx

N.º K: K221871 · 2022-08-30

Fecha de decisión2022-08-30

Código de productoNFT

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx is the device name listed in this FDA 510(k) record. The listed applicant is Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K221871. 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 Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx?

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Healstone Biotech, Inc.. The 510(k) number is K221871.

When did Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx receive FDA 510(k) clearance?

Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx received FDA 510(k) clearance on 2022-08-30, under 510(k) number K221871.

Who is the listed applicant for Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx?

The FDA 510(k) record lists Healstone Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx?

The FDA product code for Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx is NFT.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Healstone Biotech, Inc. como solicitante

K212418hCG One Step Pregnancy Test K191841Copa de Prueba de Orina de Drogas Multipanel Accurate

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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.