FDA 510(k)

Quantisal® II 口腔液体采集装置

K号: K223781 · 2023-07-28

决定日期2023-07-28

产品代码PJD

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

Quantisal™ II Oral Fluid Collection Device is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K223781. The device is classified under product code PJD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantisal™ II Oral Fluid Collection Device?

Quantisal™ II Oral Fluid Collection Device is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Immunalysis Corporation. The 510(k) number is K223781.

When did Quantisal™ II Oral Fluid Collection Device receive FDA 510(k) clearance?

Quantisal™ II Oral Fluid Collection Device received FDA 510(k) clearance on 2023-07-28, under 510(k) number K223781.

Who is the listed applicant for Quantisal™ II Oral Fluid Collection Device?

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

What is the FDA product code for Quantisal™ II Oral Fluid Collection Device?

The FDA product code for Quantisal™ II Oral Fluid Collection Device is PJD.

列明Immunalysis 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。

K252520SEFRIA® 水合吗啡口腔液体 K232898Quantisal® 口腔液体采集装置 K203564SEFRIA吗啡口腔液体酶联免疫测定 K203647SEFRIA甲基苯丙胺口腔液体酶联免疫测定 K203489SEFRIA PCP 口腔液体酶联免疫测定 K200801Quantisal口腔液体收集装置

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