FDA 510(k)

ImmuGlo HEp-2 Elite IFA

K号: K172745 · 2018-06-05

决定日期2018-06-05

产品代码DHN

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决定实质等同

器械摘要

ImmuGlo HEp-2 Elite IFA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K172745. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImmuGlo HEp-2 Elite IFA?

ImmuGlo HEp-2 Elite IFA is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K172745.

When did ImmuGlo HEp-2 Elite IFA receive FDA 510(k) clearance?

ImmuGlo HEp-2 Elite IFA received FDA 510(k) clearance on 2018-06-05, under 510(k) number K172745.

Who is the listed applicant for ImmuGlo HEp-2 Elite IFA?

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

What is the FDA product code for ImmuGlo HEp-2 Elite IFA?

The FDA product code for ImmuGlo HEp-2 Elite IFA is DHN.

列明Immco 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。

K172078ImmuLisa 增强型RNA POL III 抗体ELISA K163133ImmuLisa 增强型AMA IgG 抗体ELISA；ImmuLisa 增强型AMA IgA/IgG/IgM 抗体ELISA K163177ImmuLisa 增强型麦醇溶蛋白IgA 抗体ELISA，ImmuLisa 增强型麦醇溶蛋白IgG 抗体ELISA K162788ImmuLisa 增强型B2GP1 IgA 抗体ELISA，ImmuLisa 增强型B2GP1 IgG 抗体ELISA，ImmuLisa 增强型B2GP1 IgM 抗体ELISA，ImmuLisa 增强型B2GP1 IgA/IgG/IgM 抗体ELISA K151559ImmuLisa 增强型着丝粒抗体ELISA

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