FDA 510(k)

Accula Strep A Test

K号: K201269 · 2020-11-09

决定日期2020-11-09

产品代码PGX

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决定实质等同

器械摘要

Accula Strep A Test is the device name listed in this FDA 510(k) record. The listed applicant is Mesa Biotech, Inc.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K201269. 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 Accula Strep A Test?

Accula Strep A Test is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Mesa Biotech, Inc.. The 510(k) number is K201269.

When did Accula Strep A Test receive FDA 510(k) clearance?

Accula Strep A Test received FDA 510(k) clearance on 2020-11-09, under 510(k) number K201269.

Who is the listed applicant for Accula Strep A Test?

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

What is the FDA product code for Accula Strep A Test?

The FDA product code for Accula Strep A Test is PGX.

列明Mesa Biotech, 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。

K181443Accula RSV Test K171641Accula Flu A/Flu B Test

相关器械（代码：PGX）

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。

K260047cobas Strep A 核酸检测，用于cobas Liat系统（07341911190）；cobas Strep A 质量控制试剂盒（07402678190）Roche Molecular Systems, Inc.K260333LIAISON NES A组链球菌；LIAISON NES A组链球菌控制拭子套件Diasorin Molecular, LLC K183366GenePOC Strep AGenepoc, Inc.K173653Alere i 链球菌A 2，Alere i 仪器，Alere i 链球菌A 2控制拭子套装Alere Scarborough, Inc.K173398Xpert Xpress 链球菌ACepheid K172402ARIES Group A Strep 测试，ARIES Group A Strep 测试方案文件包Luminex Corporation

官方来源

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