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)

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

K-Number: K250067 · 2025-02-20

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2025-02-20
Product CodeNGL
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-20 under approval number K250067. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K250067.

When was Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro approved by the FDA?

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro received FDA 510(k) clearance on 2025-02-20, under approval number K250067.

What company makes Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is manufactured by Guangzhou Decheng Biotechnology Co., Ltd..

What is the FDA product code for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

The FDA product code for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro is NGL.

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 Guangzhou Decheng Biotechnology Co., Ltd.

K222305MissLan™ Digital Pregnancy Rapid Test K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

View all 8 devices →

Related Devices (Code: NGL)

K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupHangzhou Clongene Biotech Co., Ltd. K193480BIOEASY Multi-Drug Test CupShenzhen Bioeasy Biotechnology Co., Ltd. K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd. K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLC K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, 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.

↑