FDA 510(k)

OneTouch Delica Plus 穿刺系統

K 號：K221546 · 2022-08-23

決定日期2022-08-23

產品代碼QRL

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

OneTouch Delica Plus Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Polyslider Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K221546. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OneTouch Delica Plus Lancing System?

OneTouch Delica Plus Lancing System is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Asahi Polyslider Co., Ltd.. The 510(k) number is K221546.

When did OneTouch Delica Plus Lancing System receive FDA 510(k) clearance?

OneTouch Delica Plus Lancing System received FDA 510(k) clearance on 2022-08-23, under 510(k) number K221546.

Who is the listed applicant for OneTouch Delica Plus Lancing System?

The FDA 510(k) record lists Asahi Polyslider Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneTouch Delica Plus Lancing System?

The FDA product code for OneTouch Delica Plus Lancing System is QRL.

其他以 Asahi Polyslider Co., Ltd. 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。

K222084OneTouch Delica 安全性，HemoCue 安全針，Assure 針及 Assure 針 Plus，Capiject 安全針，嬰兒足跟針，預產期足跟針

相關器械（代碼：QRL）

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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