Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

K-Number: K233062 · 2023-11-02

ApplicantVivachek Biotech (Hangzhou) Co., Ltd.
Decision Date2023-11-02
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx is a medical device manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-11-02 under approval number K233062. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx?

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K233062.

When was BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx approved by the FDA?

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx received FDA 510(k) clearance on 2023-11-02, under approval number K233062.

What company makes BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx?

BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx is manufactured by Vivachek Biotech (Hangzhou) Co., Ltd..

What is the FDA product code for BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx?

The FDA product code for BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx is NFT.

Related Clinical Trials

NCT07571226 Identification and Molecular Characterisation of Urban-environmental Stress Patterns Affecting Mental Illness NOT_YET_RECRUITING NCT07288593 INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention NOT_YET_RECRUITING

Other Devices by Vivachek Biotech (Hangzhou) Co., Ltd.

K192957VivaChek Blood Glucose and B-Ketone Monitoring System K222667Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx K233058VivaChek Link Plus Blood Glucose Monitoring System K231978BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 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

View all 9 devices →

Related Devices (Code: NFT)

K170049AssureTech Panel Dip Test, AssureTech Quick Cup TestAssure Tech. (Hangzhou) Co, Ltd. K182701Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. K182530BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K181968SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardSafecare Biotech (Hangzhou) Co., Ltd. K181768AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. K180349AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd.

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.

↑