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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 the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) 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. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K250067.

When did Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro receive FDA 510(k) clearance?

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

Who is the listed applicant for Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro?

The FDA 510(k) record lists Guangzhou Decheng Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: NGL)

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.

K253567Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip CardHealgen Scientific,, LLCK250803Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test CupAnhui Deepblue Medical Technological Co., Ltd.K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup PlusGuangzhou Decheng Biotechnology Co., Ltd.K243365Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test CupHealgen Scientific,, LLCK243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home TestEterbio, Inc.K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech 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.

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