FDA 510(k)

CHIRAVAC 血液采集针

K号: K201009 · 2021-07-21

决定日期2021-07-21

产品代码JKA

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决定实质等同

器械摘要

CHIRAVAC Blood Collection Needles is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T. Injecta. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K201009. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CHIRAVAC Blood Collection Needles?

CHIRAVAC Blood Collection Needles is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Chirana T. Injecta. The 510(k) number is K201009.

When did CHIRAVAC Blood Collection Needles receive FDA 510(k) clearance?

CHIRAVAC Blood Collection Needles received FDA 510(k) clearance on 2021-07-21, under 510(k) number K201009.

Who is the listed applicant for CHIRAVAC Blood Collection Needles?

The FDA 510(k) record lists Chirana T. Injecta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHIRAVAC Blood Collection Needles?

The FDA product code for CHIRAVAC Blood Collection Needles is JKA.

列明Chirana T. Injecta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。

K242434胰岛素注射器 K220614MEDOJECT 细针 K201044CHIRANA胰岛素注射器

相关器械（代码：JKA）

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。

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官方来源

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