FDA 510(k)

Healgen 链球菌A快速测试条（咽喉拭子）

K号: K212623 · 2022-03-16

决定日期2022-03-16

产品代码GTY

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决定实质等同

器械摘要

Healgen Strep A Rapid Test Strip (Throat Swab) is the device name listed in this FDA 510(k) record. The listed applicant is Healgen Scientific,, LLC. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K212623. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Healgen Strep A Rapid Test Strip (Throat Swab)?

Healgen Strep A Rapid Test Strip (Throat Swab) is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Healgen Scientific,, LLC. The 510(k) number is K212623.

When did Healgen Strep A Rapid Test Strip (Throat Swab) receive FDA 510(k) clearance?

Healgen Strep A Rapid Test Strip (Throat Swab) received FDA 510(k) clearance on 2022-03-16, under 510(k) number K212623.

Who is the listed applicant for Healgen Strep A Rapid Test Strip (Throat Swab)?

The FDA 510(k) record lists Healgen Scientific,, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab)?

The FDA product code for Healgen Strep A Rapid Test Strip (Throat Swab) is GTY.

列明Healgen Scientific,, LLC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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