FDA 510(k)

ARIES Group A Strep 测试，ARIES Group A Strep 测试方案文件包

K号: K172402 · 2017-10-30

决定日期2017-10-30

产品代码PGX

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决定实质等同

器械摘要

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-10-30 under 510(k) number K172402. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is a medical device that received FDA 510(k) clearance on 2017-10-30. The listed applicant is Luminex Corporation. The 510(k) number is K172402.

When did ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit receive FDA 510(k) clearance?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit received FDA 510(k) clearance on 2017-10-30, under 510(k) number K172402.

Who is the listed applicant for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

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

What is the FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

The FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is PGX.

列明Luminex 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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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。