FDA 510(k)

HemosIL HIT-Ab(PF4-H)，HemosIL HIT-Ab(PF4-H)对照

K号: K153137 · 2016-07-08

决定日期2016-07-08

产品代码LCO

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决定实质等同

器械摘要

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls 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 2016-07-08 under 510(k) number K153137. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K153137.

When did HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls receive FDA 510(k) clearance?

HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153137.

Who is the listed applicant for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

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 HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls?

The FDA product code for HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls is LCO.

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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。