FDA 510(k)

SeraQuest Herpes Type 1 Specific IgG

K号: K162276 · 2016-10-01

决定日期2016-10-01

产品代码MXJ

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决定实质等同

器械摘要

SeraQuest Herpes Type 1 Specific IgG is the device name listed in this FDA 510(k) record. The listed applicant is Quest International, Inc.. It received FDA 510(k) clearance on 2016-10-01 under 510(k) number K162276. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SeraQuest Herpes Type 1 Specific IgG?

SeraQuest Herpes Type 1 Specific IgG is a medical device that received FDA 510(k) clearance on 2016-10-01. The listed applicant is Quest International, Inc.. The 510(k) number is K162276.

When did SeraQuest Herpes Type 1 Specific IgG receive FDA 510(k) clearance?

SeraQuest Herpes Type 1 Specific IgG received FDA 510(k) clearance on 2016-10-01, under 510(k) number K162276.

Who is the listed applicant for SeraQuest Herpes Type 1 Specific IgG?

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

What is the FDA product code for SeraQuest Herpes Type 1 Specific IgG?

The FDA product code for SeraQuest Herpes Type 1 Specific IgG is MXJ.

列明Quest International, 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。

K181514SeraQuest HSV Type 2 Specific IgG K152353SeraQuest HSV Type 2 Specific IgG

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。