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FDA 510(k)

MissLan® 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

K 號：K240643 · 2024-06-21

申請人Guangzhou Decheng Biotechnology Co., Ltd.
決定日期2024-06-21
產品代碼LCX
諮詢委員會CH
決定相當於

器材摘要

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream 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 2024-06-21 under 510(k) number K240643. 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 Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K240643.

When did MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream receive FDA 510(k) clearance?

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream received FDA 510(k) clearance on 2024-06-21, under 510(k) number K240643.

Who is the listed applicant for MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

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 Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

The FDA product code for MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is LCX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K251040MissLan® 預早偵測數位懷孕檢測儀；MissLan® 預早結果數位懷孕檢測儀K250067Dochek® 多藥尿液檢測杯；Dochek® 多藥尿液檢測杯 ProK242428Dochek® 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。

K251040MissLan® 預早偵測數位懷孕檢測儀；MissLan® 預早結果數位懷孕檢測儀Guangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell Plus™數位早期懷孕檢測器Hangzhou AllTest Biotech Co., Ltd.K250117法斯特孕檢快速測試條；Fastep人類絲裂原子基因(HCG)快速測試條Assure Tech., LLCK242135Synthgene 首頁測試 HCG 測試條；Synthgene 首頁測試 HCG 測試卡式；Synthgene 首頁測試 HCG 測試中間流Nanjing Synthgene Medical Technology Co., Ltd.K243573法斯特早期懷孕快速測試條；法斯特早期懷孕快速測試卡式；法斯特早期懷孕快速測試中間流Assure Tech., LLCK241394iHealth® 早期懷孕檢測；iHealth® 早期懷孕檢測試紙Andon Health Co, Ltd.

官方來源

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