免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

CLEARinse CTS 样本收集和运输系统

K号: K221664 · 2023-07-03

决定日期2023-07-03
产品代码QBD
咨询委员会抱歉,您提供的内容“MI”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

CLEARinse CTS Specimen Collection and Transport System is the device name listed in this FDA 510(k) record. The listed applicant is Aardvark Medical, Inc.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K221664. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CLEARinse CTS Specimen Collection and Transport System?

CLEARinse CTS Specimen Collection and Transport System is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Aardvark Medical, Inc.. The 510(k) number is K221664.

When did CLEARinse CTS Specimen Collection and Transport System receive FDA 510(k) clearance?

CLEARinse CTS Specimen Collection and Transport System received FDA 510(k) clearance on 2023-07-03, under 510(k) number K221664.

Who is the listed applicant for CLEARinse CTS Specimen Collection and Transport System?

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

What is the FDA product code for CLEARinse CTS Specimen Collection and Transport System?

The FDA product code for CLEARinse CTS Specimen Collection and Transport System is QBD.

相关临床试验

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。

相关器械(代码:QBD)

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。

官方来源

在 FDA 数据库中查看 →

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。

↑