FDA 510(k)

單步懷孕檢測

K 號：K210341 · 2022-03-10

決定日期2022-03-10

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

One Step Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Spd Swiss Precision Diagnostics GmbH. It received FDA 510(k) clearance on 2022-03-10 under 510(k) number K210341. 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 One Step Pregnancy Test?

One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-03-10. The listed applicant is Spd Swiss Precision Diagnostics GmbH. The 510(k) number is K210341.

When did One Step Pregnancy Test receive FDA 510(k) clearance?

One Step Pregnancy Test received FDA 510(k) clearance on 2022-03-10, under 510(k) number K210341.

Who is the listed applicant for One Step Pregnancy Test?

The FDA 510(k) record lists Spd Swiss Precision Diagnostics GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Step Pregnancy Test?

The FDA product code for One Step Pregnancy Test is LCX.

其他以 Spd Swiss Precision Diagnostics GmbH 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。

K240025Clearblue® 早期檢測懷孕試劑 K213379Clearblue® 早期懷孕檢測 K200913Clearblue® 早期數位懷孕檢測

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。