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FDA 510(k)

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup

K-Number: K232659 · 2023-12-13

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2023-12-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-13 under approval number K232659. 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 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup?

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K232659.

When was Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup approved by the FDA?

Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2023-12-13, under approval number K232659.

What company makes Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup?

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

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

The FDA product code for Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup is DJG.

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Other Devices by Guangzhou Decheng Biotechnology Co., Ltd.

K222305MissLan™ Digital Pregnancy Rapid Test 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 K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

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Related Devices (Code: DJG)

K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardCo-Innovation Biotech Co., Ltd. K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 TestsChemtron Biotech, Inc. K173183CEDIA Heroin Metabolite (6-AM) AssayMicrogenics Corporation K172910Emit II Plus Oxycodone AssaySiemens Healthcare Diagnostics, Inc. K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine CalibratorsImmunalysis Corporation K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetMicrogenics Corporation

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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