FDA 510(k)

VeriClear Digital Early Result Pregnancy Test

K番号: K182328 · 2019-05-15

決定日2019-05-15

製品コードLCX

諮問委員会CH 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてTrue Diagnostics, Inc.を記載するその他の記録

K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)

公式ソース

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