FDA 510(k)

Aptiva 慢性炎症性肠病 IgA 试剂

K号: K193604 · 2021-06-16

决定日期2021-06-16

产品代码MVM

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决定实质等同

器械摘要

Aptiva Celiac Disease IgA Reagent is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K193604. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aptiva Celiac Disease IgA Reagent?

Aptiva Celiac Disease IgA Reagent is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K193604.

When did Aptiva Celiac Disease IgA Reagent receive FDA 510(k) clearance?

Aptiva Celiac Disease IgA Reagent received FDA 510(k) clearance on 2021-06-16, under 510(k) number K193604.

Who is the listed applicant for Aptiva Celiac Disease IgA Reagent?

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

What is the FDA product code for Aptiva Celiac Disease IgA Reagent?

The FDA product code for Aptiva Celiac Disease IgA Reagent is MVM.

列明Inova 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。

K243979Aptiva APS IgA 试剂 K223093Aptiva APS IgG 试剂; Aptiva APS IgM 试剂 K213403Aptiva CTD 基础试剂 K200230Aptiva 慢性炎症性肠病 IgG 试剂 K192916NOVA Lite DAPI dsDNA Crithidia luciliae试剂盒 K190088QUANTA Flash RF IgM 试剂，QUANTA Flash RF IgA 试剂

查看所有 16 个设备 →

官方来源

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