FDA 510(k)

MICROLET NEXT 穿刺器，MICROLET 刺針

K 號：K220633 · 2022-06-03

決定日期2022-06-03

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

MICROLET NEXT lancing device, MICROLET Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220633. 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 MICROLET NEXT lancing device, MICROLET Lancet?

MICROLET NEXT lancing device, MICROLET Lancet is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K220633.

When did MICROLET NEXT lancing device, MICROLET Lancet receive FDA 510(k) clearance?

MICROLET NEXT lancing device, MICROLET Lancet received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220633.

Who is the listed applicant for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA 510(k) record lists Ascensia Diabetes Care U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA product code for MICROLET NEXT lancing device, MICROLET Lancet is QRL.

其他以 Ascensia Diabetes Care U.S., 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。

K250813MICROLET®NEXT 2 鋸刺器 K241787CONTOUR® PLUS BLUE 血糖監測系統；CONTOUR® NEXT GEN 血糖監測系統 K241810MICROLET®NEXT 刺針 K223293CONTOUR® NEXT GEN 血糖監測系統 K162336Contour Next EZ 血糖監測系統 K160430Contour Next Link 遥感式血糖監測系統，Contour Next 血糖監測系統

查看所有 7 項裝置 →

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。

K262135穿刺器Tianjin Huahong Technology Co., Ltd.K262211蘭塞特Tianjin Huahong Technology Co., Ltd.K260122針刺器（PressGo，LDE3，LDE3AST，LDE5，EasyStep）SteriLance Medical (Suzhou), Inc.K253706針刺器（HH-XV-T）Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 鋸刺器Ascensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX)；刺針設備（HH-X-T，HH-XV-T，HH-XVI-T，HH-XVII-T，HH-XVIII-T，HH-XIX，HH-XXI-T，HH-XXII-T，HH-XXIII-T，HH-XXIV-T，HH-XXV-T，HH-XXVI-T，HH-XXVIII-T，HH-XXIX-T，HH-XXX-T，HH-XIII-T，HH-XXVII-T）Tianjin Huahong Technology Co., Ltd.

官方來源

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