FDA 510(k)

ImmuLisa 增强型着丝粒抗体ELISA

K号: K151559 · 2016-03-11

决定日期2016-03-11

产品代码LJM

咨询委员会抱歉，您提供的信息不完整，无法进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ImmuLisa Enhanced Centromere Antibody ELISA 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 2016-03-11 under 510(k) number K151559. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImmuLisa Enhanced Centromere Antibody ELISA?

ImmuLisa Enhanced Centromere Antibody ELISA is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K151559.

When did ImmuLisa Enhanced Centromere Antibody ELISA receive FDA 510(k) clearance?

ImmuLisa Enhanced Centromere Antibody ELISA received FDA 510(k) clearance on 2016-03-11, under 510(k) number K151559.

Who is the listed applicant for ImmuLisa Enhanced Centromere Antibody ELISA?

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 ImmuLisa Enhanced Centromere Antibody ELISA?

The FDA product code for ImmuLisa Enhanced Centromere Antibody ELISA is LJM.

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。

K172745ImmuGlo HEp-2 Elite IFA 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

官方来源

在 FDA 数据库中查看 →

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。