FDA 510(k)

NOVA Lite DAPI dsDNA Crithidia luciliae试剂盒

K号: K192916 · 2020-12-11

决定日期2020-12-11

产品代码KTL

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决定实质等同

器械摘要

NOVA Lite DAPI dsDNA Crithidia luciliae Kit 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 2020-12-11 under 510(k) number K192916. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

NOVA Lite DAPI dsDNA Crithidia luciliae Kit is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K192916.

When did NOVA Lite DAPI dsDNA Crithidia luciliae Kit receive FDA 510(k) clearance?

NOVA Lite DAPI dsDNA Crithidia luciliae Kit received FDA 510(k) clearance on 2020-12-11, under 510(k) number K192916.

Who is the listed applicant for NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

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 NOVA Lite DAPI dsDNA Crithidia luciliae Kit?

The FDA product code for NOVA Lite DAPI dsDNA Crithidia luciliae Kit is KTL.

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。

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