FDA 510(k)

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader

Número K: K240124 · 2024-06-14

RequerenteVivachek Biotech (Hangzhou) Co., Ltd.

Data da decisão2024-06-14

Código do produtoDJG

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA 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 2024-06-14 under 510(k) number K240124. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader?

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K240124.

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

BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader received FDA 510(k) clearance on 2024-06-14, under 510(k) number K240124.

Who is the listed applicant for BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA 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 Test Kit; BioSieve™ ToxiSmart FIA Reader?

The FDA product code for BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader is DJG.

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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 K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System K233058VivaChek Link Plus Blood Glucose Monitoring System K233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: DJG)

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited K253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLC K251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Fonte oficial

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