FDA 510(k)

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

K 號：K250117 · 2025-02-13

決定日期2025-02-13

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Assure Tech., LLC. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K250117. 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 FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Assure Tech., LLC. The 510(k) number is K250117.

When did FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette receive FDA 510(k) clearance?

FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette received FDA 510(k) clearance on 2025-02-13, under 510(k) number K250117.

Who is the listed applicant for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

FDA 510(k) 記錄將 Assure Tech., LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette?

The FDA product code for FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette is LCX.

其他以 Assure Tech., LLC 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。

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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.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.K240242HCG居家使用懷孕試劑條（膠體金），HCG居家使用懷孕試劑卡（膠體金），HCG居家使用懷孕試劑中間試劑（膠體金）Anhui Deepblue Medical Technology Co., Ltd.

官方來源

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