FDA 510(k)

MissLan® 預早偵測數位懷孕檢測儀；MissLan® 預早結果數位懷孕檢測儀

K 號：K251040 · 2025-09-09

申請人Guangzhou Decheng Biotechnology Co., Ltd.

決定日期2025-09-09

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test 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 2025-09-09 under 510(k) number K251040. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K251040.

When did MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test receive FDA 510(k) clearance?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test received FDA 510(k) clearance on 2025-09-09, under 510(k) number K251040.

Who is the listed applicant for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

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 MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

The FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is LCX.

其他以 Guangzhou Decheng Biotechnology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250067Dochek® 多藥尿液檢測杯；Dochek® 多藥尿液檢測杯 Pro K242428Dochek® 藥物濾尿試紙，Dochek® 藥物濾尿試紙加強版，Dochek® 藥物濾尿試卡，Dochek® 藥物濾尿試卡加強版，Dochek® 藥物濾尿試杯以及Dochek® 藥物濾尿試杯加強版 K240643MissLan® 早期檢測懷孕試紙；MissLan® 早期檢測懷孕試劑盒；MissLan® 早期檢測懷孕試劑中間流 K240698Dochek® 多藥尿液測試濾卡 Rx；Dochek® 多藥尿液測試濾卡 K232659Dochek® 多藥尿液檢測杯Rx, Dochek® 多藥尿液檢測杯 K230038MissLan® 妊娠快速檢測（試紙），MissLan® 妊娠快速檢測（中間流）

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相關器械（代碼：LCX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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