FDA 510(k)

預覽數位懷孕檢測器

K 號：K173229 · 2018-03-12

決定日期2018-03-12

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

Preview Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2018-03-12 under 510(k) number K173229. 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 Preview Digital Pregnancy Test?

Preview Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2018-03-12. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K173229.

When did Preview Digital Pregnancy Test receive FDA 510(k) clearance?

Preview Digital Pregnancy Test received FDA 510(k) clearance on 2018-03-12, under 510(k) number K173229.

Who is the listed applicant for Preview Digital Pregnancy Test?

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

What is the FDA product code for Preview Digital Pregnancy Test?

The FDA product code for Preview Digital Pregnancy Test is LCX.

其他以 Guangzhou Wondfo 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。

K260065SAFElife T-Dip 多藥尿液檢測組合；SAFElife T-Dip 多藥尿液檢測組合 Dx K252550SAFElife T-Cup 多藥尿液檢測杯；SAFElife T-Cup 多藥尿液檢測杯 Dx K251289WELLlife COVID-19 抗原檢測藥品許可證 K241317Wondfo 2019-nCoV 抗原檢測（橫向流測試法）K241741SAFElife™ 藥物尿檢測儀（試劑條）；SAFElife™ 藥物（FTY）尿檢測試劑條；SAFElife™ T-Dip 藥物尿檢測儀（滴測卡）；SAFElife™ T-Dip 藥物（FTY）尿檢測試劑板 K202567Wondfo T-Dip 多藥尿液檢測組合，Wondfo T-Dip 多藥尿液檢測組合 Rx

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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., LLC K242135Synthgene 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., LLC K241394iHealth® 早期懷孕檢測；iHealth® 早期懷孕檢測試紙Andon Health Co, Ltd.

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