Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup

N.º K: K250803 · 2025-04-15

SolicitanteAnhui Deepblue Medical Technological Co., Ltd.
Fecha de decisión2025-04-15
Código de productoNGL
Comité asesorTX
DecisiónSubstantially Equivalent

Resumen del dispositivo

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K250803. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is Anhui Deepblue Medical Technological Co., Ltd.. The 510(k) number is K250803.

When did Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup receive FDA 510(k) clearance?

Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup received FDA 510(k) clearance on 2025-04-15, under 510(k) number K250803.

Who is the listed applicant for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA 510(k) record lists Anhui Deepblue Medical Technological Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup?

The FDA product code for Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup is NGL.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: NGL)

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.

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLCK250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLCK243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene 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.

↑