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FDA 510(k)

CLUNGENE HCG懷孕快速測試儀盒，CLUNGENE HCG懷孕快速測試條，CLUNGENE HCG懷孕快速測試中間流

K 號：K193132 · 2019-12-11

申請人Hangzhou Clongene Biotech Co., Ltd.
決定日期2019-12-11
產品代碼LCX
諮詢委員會CH
決定相當於

器材摘要

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K193132. 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 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream?

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K193132.

When did CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream receive FDA 510(k) clearance?

CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2019-12-11, under 510(k) number K193132.

Who is the listed applicant for CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream?

The FDA product code for CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid 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 Hangzhou Clongene Biotech 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。

K253318Clungene RSV 抗原快速檢測K252118CLUNGENE 多藥檢測易杯；CLUNGENE 多藥家用檢測易杯K242802CLUNGENE 藥物濟用試劑盒；CLUNGENE 藥物測試劑盒K190412CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯K181790CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯K180255CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯

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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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