FDA 510(k)

VeriClear數位早期結果懷孕檢測

K 號：K182328 · 2019-05-15

決定日期2019-05-15

產品代碼LCX

諮詢委員會CH

決定相當於

器材摘要

VeriClear Digital Early Result Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is True Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-05-15 under 510(k) number K182328. 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 VeriClear Digital Early Result Pregnancy Test?

VeriClear Digital Early Result Pregnancy Test is a medical device that received FDA 510(k) clearance on 2019-05-15. The listed applicant is True Diagnostics, Inc.. The 510(k) number is K182328.

When did VeriClear Digital Early Result Pregnancy Test receive FDA 510(k) clearance?

VeriClear Digital Early Result Pregnancy Test received FDA 510(k) clearance on 2019-05-15, under 510(k) number K182328.

Who is the listed applicant for VeriClear Digital Early Result Pregnancy Test?

The FDA 510(k) record lists True Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VeriClear Digital Early Result Pregnancy Test?

The FDA product code for VeriClear Digital Early Result Pregnancy Test is LCX.

其他以 True Diagnostics, Inc. 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。

K172257TrueDX hCG 預測結果懷孕檢測（中間流格式），TrueDX hCG 預測結果懷孕檢測（卡式格式），VeriClear 預測結果懷孕檢測（中間流格式），VeriClear 預測結果懷孕檢測（卡式格式）

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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