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FDA 510(k)

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

K-Number: K240124 · 2024-06-14

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.
Decision Date2024-06-14
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Vivachek Biotech (Hangzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261280BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelK252554Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupK241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart ReaderK222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring SystemK233058VivaChek Link Plus Blood Glucose Monitoring SystemK233062BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

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Related Devices (Code: DJG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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