FDA 510(k)

Acro HCG 孕检快速测试

K号: K180771 · 2018-05-18

决定日期2018-05-18

产品代码LCX

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决定实质等同

器械摘要

Acro HCG Pregnancy Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Acro Biotech, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180771. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acro HCG Pregnancy Rapid Test?

Acro HCG Pregnancy Rapid Test is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Acro Biotech, Inc.. The 510(k) number is K180771.

When did Acro HCG Pregnancy Rapid Test receive FDA 510(k) clearance?

Acro HCG Pregnancy Rapid Test received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180771.

Who is the listed applicant for Acro HCG Pregnancy Rapid Test?

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

What is the FDA product code for Acro HCG Pregnancy Rapid Test?

The FDA product code for Acro HCG Pregnancy Rapid Test is LCX.

列明Acro 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。

K172512ACRO HCG 孕检快速测试

相关器械（代码：LCX）

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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