FDA 510(k)

droplet®個人式針刺器

K 號：K250016 · 2025-07-01

決定日期2025-07-01

產品代碼QRK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

droplet® personal lancets is the device name listed in this FDA 510(k) record. The listed applicant is Htl-Strefa S.A. It received FDA 510(k) clearance on 2025-07-01 under 510(k) number K250016. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the droplet® personal lancets?

droplet® personal lancets is a medical device that received FDA 510(k) clearance on 2025-07-01. The listed applicant is Htl-Strefa S.A. The 510(k) number is K250016.

When did droplet® personal lancets receive FDA 510(k) clearance?

droplet® personal lancets received FDA 510(k) clearance on 2025-07-01, under 510(k) number K250016.

Who is the listed applicant for droplet® personal lancets?

The FDA 510(k) record lists Htl-Strefa S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for droplet® personal lancets?

The FDA product code for droplet® personal lancets is QRK.

其他以 Htl-Strefa S.A 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：QRK）

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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官方來源

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