FDA 510(k)

AssureTech Panel Dip Test, AssureTech Quick Cup Test

N.º K: K170049 · 2017-05-02

SolicitanteAssure Tech. (Hangzhou) Co, Ltd.

Fecha de decisión2017-05-02

Código de productoNFT

Comité asesorTX

DecisiónSubstantially Equivalent

Resumen del dispositivo

AssureTech Panel Dip Test, AssureTech Quick Cup Test is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K170049. 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 AssureTech Panel Dip Test, AssureTech Quick Cup Test?

AssureTech Panel Dip Test, AssureTech Quick Cup Test is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Assure Tech. (Hangzhou) Co, Ltd.. The 510(k) number is K170049.

When did AssureTech Panel Dip Test, AssureTech Quick Cup Test receive FDA 510(k) clearance?

AssureTech Panel Dip Test, AssureTech Quick Cup Test received FDA 510(k) clearance on 2017-05-02, under 510(k) number K170049.

Who is the listed applicant for AssureTech Panel Dip Test, AssureTech Quick Cup Test?

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

What is the FDA product code for AssureTech Panel Dip Test, AssureTech Quick Cup Test?

The FDA product code for AssureTech Panel Dip Test, AssureTech Quick Cup Test 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 Assure Tech. (Hangzhou) Co, Ltd. como solicitante

K233174FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests K181768AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K180349AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K161044AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)

Ver todos los 7 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.

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.