FDA 510(k)

Savanna HSV 1+2/VZV 测定，Savanna HSV 1+2/VZV 控制套件，Savanna 仪器

K号: K232286 · 2023-12-20

决定日期2023-12-20

产品代码PGI

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决定实质等同

器械摘要

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K232286. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Quidel Corporation. The 510(k) number is K232286.

When did Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument receive FDA 510(k) clearance?

Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument received FDA 510(k) clearance on 2023-12-20, under 510(k) number K232286.

Who is the listed applicant for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument?

The FDA product code for Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument is PGI.

列明Quidel Corporation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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