FDA 510(k)

人绒毛膜促性腺激素一步法妊娠检测

K号: K212418 · 2022-06-30

决定日期2022-06-30

产品代码LCX

咨询委员会CH 请注意，您提供的文本“CH”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

hCG One Step Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Healstone Biotech, Inc.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K212418. 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 hCG One Step Pregnancy Test?

hCG One Step Pregnancy Test is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is Healstone Biotech, Inc.. The 510(k) number is K212418.

When did hCG One Step Pregnancy Test receive FDA 510(k) clearance?

hCG One Step Pregnancy Test received FDA 510(k) clearance on 2022-06-30, under 510(k) number K212418.

Who is the listed applicant for hCG One Step Pregnancy Test?

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

What is the FDA product code for hCG One Step Pregnancy Test?

The FDA product code for hCG One Step Pregnancy Test is LCX.

列明Healstone 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。

K221871Healstone 准确度 (TM) 滥用药物尿液测试杯，Healstone 准确度 (TM) 滥用药物尿液测试杯 Rx K191841Accurate Multi Panel药物尿液测试杯。

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。

K251040MissLan® 早期检测数字早孕测试；MissLan® 早期结果数字早孕测试Guangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM 数字型早孕测试Hangzhou AllTest Biotech Co., Ltd.K250117FaStep 妊娠快速测试卡式；Fastep HCG 快速测试卡式Assure Tech., LLC K242135Synthgene家庭测试HCG测试条；Synthgene家庭测试HCG测试卡；Synthgene家庭测试HCG测试中流Nanjing Synthgene Medical Technology Co., Ltd.K243573FaStep 早期妊娠快速测试条；FaStep 早期妊娠快速测试卡式；FaStep 早期妊娠快速测试中段Assure Tech., LLC K241394iHealth® 早早孕测试；iHealth® 早早孕测试条Andon Health Co, Ltd.

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