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 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 2023-12-13 under 510(k) 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. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K232659.

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

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

Who is the listed applicant for Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup?

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 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 records listing Guangzhou Decheng Biotechnology Co., Ltd. as applicant

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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.