FDA 510(k)

Shinetell數位懷孕檢測器

K 號：K241978 · 2024-08-13

決定日期2024-08-13

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

Shinetell Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241978. 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 Shinetell Digital Pregnancy Test?

Shinetell Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Hangzhou AllTest Biotech Co., Ltd.. The 510(k) number is K241978.

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

Shinetell Digital Pregnancy Test received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241978.

Who is the listed applicant for Shinetell Digital Pregnancy Test?

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

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

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

其他以 Hangzhou AllTest 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。

K260342AllTest Strep A Rapid Test K252607AllTest 尿路感染檢測試劑 K251053Shinetell Plus™數位早期懷孕檢測器 K250727AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup K242576AllTest 病毒傳播中間體 K244043AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

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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.

官方來源

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