FDA 510(k)

Dochek®多药物尿液测试杯Rx，Dochek®多药物尿液测试杯

K号: K232659 · 2023-12-13

申请人Guangzhou Decheng Biotechnology Co., Ltd.

决定日期2023-12-13

产品代码DJG

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决定实质等同

器械摘要

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.

常见问题

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.

列明Guangzhou Decheng Biotechnology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251040MissLan® 早期检测数字早孕测试；MissLan® 早期结果数字早孕测试 K250067Dochek®多药物尿液测试杯；Dochek®多药物尿液测试杯Pro K242428Dochek®芬太尼尿液测试条，Dochek®芬太尼尿液测试条加强版，Dochek®芬太尼尿液测试卡，Dochek®芬太尼尿液测试卡加强版，Dochek®芬太尼尿液测试杯和Dochek®芬太尼尿液测试杯加强版 K240643MissLan® 早期检测早孕试纸；MissLan® 早期检测早孕条；MissLan® 早期检测早孕中段试纸 K240698Dochek®多药物尿液测试滴卡Rx；Dochek®多药物尿液测试滴卡 K230038MissLan® 早孕快速测试（条），MissLan® 早孕快速测试（中段）

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