FDA 510(k)

MICROLET®NEXT 2 刺针装置

K号: K250813 · 2025-05-14

决定日期2025-05-14

产品代码QRL

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

MICROLET®NEXT 2 Lancing Device 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 2025-05-14 under 510(k) number K250813. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MICROLET®NEXT 2 Lancing Device?

MICROLET®NEXT 2 Lancing Device is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K250813.

When did MICROLET®NEXT 2 Lancing Device receive FDA 510(k) clearance?

MICROLET®NEXT 2 Lancing Device received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250813.

Who is the listed applicant for MICROLET®NEXT 2 Lancing Device?

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 2 Lancing Device?

The FDA product code for MICROLET®NEXT 2 Lancing Device is QRL.

列明Ascensia Diabetes Care U.S., Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241787CONTOUR® PLUS BLUE 血糖监测系统；CONTOUR® NEXT GEN 血糖监测系统 K241810MICROLET®NEXT 刺针 K223293CONTOUR® NEXT GEN 血糖监测系统 K220633MICROLET NEXT 刺针装置，MICROLET 刺针 K162336Contour Next EZ 血糖监测系统 K160430Contour Next Link 无线血糖监测系统，Contour Next 血糖监测系统

查看所有 7 个设备 →

相关器械（代码：QRL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262135刺针Tianjin Huahong Technology Co., Ltd.K262211lancetTianjin Huahong Technology Co., Ltd.K260122穿刺器（PressGo, LDE3, LDE3AST, LDE5, EasyStep）SteriLance Medical (Suzhou), Inc.K253706刺针 (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K243306lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); 刺针 (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.K232912Facet Aurora 可重复使用注射针座Facet Technologies, LLC

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。