FDA 510(k)

HemosIL D-二聚体HS

K号: K160885 · 2016-10-27

决定日期2016-10-27

产品代码DAP

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决定实质等同

器械摘要

HemosIL D-Dimer HS 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 2016-10-27 under 510(k) number K160885. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HemosIL D-Dimer HS?

HemosIL D-Dimer HS is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K160885.

When did HemosIL D-Dimer HS receive FDA 510(k) clearance?

HemosIL D-Dimer HS received FDA 510(k) clearance on 2016-10-27, under 510(k) number K160885.

Who is the listed applicant for HemosIL D-Dimer HS?

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 D-Dimer HS?

The FDA product code for HemosIL D-Dimer HS is DAP.

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 K213426HemosIL ReadiPlasTin

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官方来源

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