FDA 510(k)

HemosIL ReadiPlasTin

K号: K213426 · 2022-08-16

决定日期2022-08-16

产品代码GJS

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决定实质等同

器械摘要

HemosIL ReadiPlasTin is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 2022-08-16 under 510(k) number K213426. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HemosIL ReadiPlasTin?

HemosIL ReadiPlasTin is a medical device that received FDA 510(k) clearance on 2022-08-16. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K213426.

When did HemosIL ReadiPlasTin receive FDA 510(k) clearance?

HemosIL ReadiPlasTin received FDA 510(k) clearance on 2022-08-16, under 510(k) number K213426.

Who is the listed applicant for HemosIL ReadiPlasTin?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemosIL ReadiPlasTin?

The FDA product code for HemosIL ReadiPlasTin is GJS.

列明Instrumentation Laboratory CO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。

K221359ACL TOP 970 CL, HemosIL CL 抗心磷脂IgM, HemosIL CL 抗ß2 糖蛋白-I IgM K223187HemosIL 液体抗-Xa K223090GEM Premier ChemSTAT K223402HemosIL von Willebrand 因子抗原 K213464HemosIL 液体抗-Xa K203790GEM Premier 5000

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官方来源

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