FDA 510(k)

刺针系统，一次性无菌 lancet，刺针

K号: K222472 · 2022-11-30

申请人Shandong Lianfa Medical Plastic Products Co. , Ltd.

决定日期2022-11-30

产品代码QRL

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决定实质等同

器械摘要

Lancing System, Sterile Lancet for Single Use, Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K222472. 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 Lancing System, Sterile Lancet for Single Use, Lancing Device?

Lancing System, Sterile Lancet for Single Use, Lancing Device is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222472.

When did Lancing System, Sterile Lancet for Single Use, Lancing Device receive FDA 510(k) clearance?

Lancing System, Sterile Lancet for Single Use, Lancing Device received FDA 510(k) clearance on 2022-11-30, under 510(k) number K222472.

Who is the listed applicant for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device is QRL.

列明Shandong Lianfa Medical Plastic Products Co. , Ltd.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。

K222376联发安全注射针（五种型号：NPA、PA、PA2、TPA和APA）

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.K250813MICROLET®NEXT 2 刺针装置Ascensia Diabetes Care U.S., Inc.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.

官方来源

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