FDA 510(k)

ORAcollect.Dx

K号: K152464 · 2016-05-26

决定日期2016-05-26

产品代码OYJ

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

ORAcollect.Dx is the device name listed in this FDA 510(k) record. The listed applicant is DNA Genotek, Inc.. It received FDA 510(k) clearance on 2016-05-26 under 510(k) number K152464. The device is classified under product code OYJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ORAcollect.Dx?

ORAcollect.Dx is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is DNA Genotek, Inc.. The 510(k) number is K152464.

When did ORAcollect.Dx receive FDA 510(k) clearance?

ORAcollect.Dx received FDA 510(k) clearance on 2016-05-26, under 510(k) number K152464.

Who is the listed applicant for ORAcollect.Dx?

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

What is the FDA product code for ORAcollect.Dx?

The FDA product code for ORAcollect.Dx is OYJ.

列明DNA Genotek, 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。

K254121Colli-Pee•Dx尿液收集套装 K212745ORAcollect®•Dx K192920Oragene®•Dx K152556Oragene Dx

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