FDA 510(k)

PF4 IgG 检测

K号: K201311 · 2020-06-18

决定日期2020-06-18

产品代码LCO

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决定实质等同

器械摘要

PF4 IgG assay is the device name listed in this FDA 510(k) record. The listed applicant is Immucor Gti Diagnostics, Inc.. It received FDA 510(k) clearance on 2020-06-18 under 510(k) number K201311. 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 PF4 IgG assay?

PF4 IgG assay is a medical device that received FDA 510(k) clearance on 2020-06-18. The listed applicant is Immucor Gti Diagnostics, Inc.. The 510(k) number is K201311.

When did PF4 IgG assay receive FDA 510(k) clearance?

PF4 IgG assay received FDA 510(k) clearance on 2020-06-18, under 510(k) number K201311.

Who is the listed applicant for PF4 IgG assay?

The FDA 510(k) record lists Immucor Gti Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PF4 IgG assay?

The FDA product code for PF4 IgG assay is LCO.

列明Immucor Gti Diagnostics, Inc.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。

K201570PF4 增强型检测

官方来源

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