FDA 510(k)

Aptiva CTD 基础试剂

K号: K213403 · 2023-09-29

决定日期2023-09-29

产品代码LLL

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决定实质等同

器械摘要

Aptiva CTD Essential 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 2023-09-29 under 510(k) number K213403. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aptiva CTD Essential Reagent?

Aptiva CTD Essential Reagent is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K213403.

When did Aptiva CTD Essential Reagent receive FDA 510(k) clearance?

Aptiva CTD Essential Reagent received FDA 510(k) clearance on 2023-09-29, under 510(k) number K213403.

Who is the listed applicant for Aptiva CTD Essential 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 CTD Essential Reagent?

The FDA product code for Aptiva CTD Essential Reagent is LLL.

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 K200230Aptiva 慢性炎症性肠病 IgG 试剂 K193604Aptiva 慢性炎症性肠病 IgA 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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