免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Let'sGetChecked 印記

K 號:K242680 · 2025-01-13

決定日期2025-01-13
產品代碼FMK
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定Unknown

器材摘要

LetsGetChecked Impress is the device name listed in this FDA 510(k) record. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K242680. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

常見問題

What is the LetsGetChecked Impress?

LetsGetChecked Impress is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Privapath Diagnostics Ltd (Dba Letsgetchecked). The 510(k) number is K242680.

When did LetsGetChecked Impress receive FDA 510(k) clearance?

LetsGetChecked Impress received FDA 510(k) clearance on 2025-01-13, under 510(k) number K242680.

Who is the listed applicant for LetsGetChecked Impress?

The FDA 510(k) record lists Privapath Diagnostics Ltd (Dba Letsgetchecked) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LetsGetChecked Impress?

The FDA product code for LetsGetChecked Impress is FMK.

相關臨床試驗

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。

相關器械(代碼:FMK)

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。

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。

↑