FDA 510(k)

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

Número K: K241869 · 2024-10-04

RequerenteVivachek Biotech (Hangzhou) Co., Ltd.

Data da decisão2024-10-04

Código do produtoNGL

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241869. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader?

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K241869.

When did BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader receive FDA 510(k) clearance?

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241869.

Who is the listed applicant for BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader?

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

What is the FDA product code for BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader?

The FDA product code for BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader is NGL.

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

K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel K252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader K233058VivaChek Link Plus Blood Glucose Monitoring System K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

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Fonte oficial

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