FDA 510(k)

一次性无菌 lancets

K号: K242622 · 2024-10-28

申请人Ningbo Caremed Medical Products Co., Ltd.

决定日期2024-10-28

产品代码QRK

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决定实质等同

器械摘要

Sterile Lancets for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K242622. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterile Lancets for Single Use?

Sterile Lancets for Single Use is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. The 510(k) number is K242622.

When did Sterile Lancets for Single Use receive FDA 510(k) clearance?

Sterile Lancets for Single Use received FDA 510(k) clearance on 2024-10-28, under 510(k) number K242622.

Who is the listed applicant for Sterile Lancets for Single Use?

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

What is the FDA product code for Sterile Lancets for Single Use?

The FDA product code for Sterile Lancets for Single Use is QRK.

列明Ningbo Caremed Medical 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。

K241848MedtFine 安全穿刺针

相关器械（代码：QRK）

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。

K262631一次性血刺针（Soft Pro，Softsure，Softsure Pro，Softsense）SteriLance Medical (Suzhou), Inc.K261634一次性血刺针（软）SteriLance Medical (Suzhou), Inc.K250016droplet®个人采血针Htl-Strefa S.A K244031一次性血刺针（软Pro）；一次性血刺针（Softsure）；一次性血刺针（Softsure Pro）；一次性血刺针（Softsense）SteriLance Medical (Suzhou), Inc.K241810MICROLET®NEXT 刺针Ascensia Diabetes Care U.S., Inc.K232330刺针系统Ningbo Medsun Medical Co., Ltd.

官方来源

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