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FDA 510(k)

ImmuLisa 增强型AMA IgG 抗体ELISA；ImmuLisa 增强型AMA IgA/IgG/IgM 抗体ELISA

K号: K163133 · 2017-08-08

申请人Immco Diagnostics, Inc.
决定日期2017-08-08
产品代码DBM
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决定实质等同

器械摘要

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM 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 2017-08-08 under 510(k) number K163133. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA?

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K163133.

When did ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA receive FDA 510(k) clearance?

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA received FDA 510(k) clearance on 2017-08-08, under 510(k) number K163133.

Who is the listed applicant for ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM 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 AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA?

The FDA product code for ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA is DBM.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 IFAK172078ImmuLisa 增强型RNA POL III 抗体ELISAK163177ImmuLisa 增强型麦醇溶蛋白IgA 抗体ELISA，ImmuLisa 增强型麦醇溶蛋白IgG 抗体ELISAK162788ImmuLisa 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ELISAK151559ImmuLisa 增强型着丝粒抗体ELISA

相关器械（代码：DBM）

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。

K181556EliA M2 免疫测定Phadia ABK163525QUANTA Flash M2 (MIT3)，QUANTA Flash M2 (MIT3) 校准器，QUANTA Flash M2 (MIT3) 控制品Inova Diagnostics, Inc.

官方来源

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