FDA 510(k)

HIGHTOP 早早孕快速测试条，HIGHTOP 早早孕快速测试卡，HIGHTOP 早早孕快速测试管

K号: K192123 · 2019-09-05

决定日期2019-09-05

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

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K192123. 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 HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Qingdao Hightop Biotech Co., Ltd.. The 510(k) number is K192123.

When did HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream receive FDA 510(k) clearance?

HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2019-09-05, under 510(k) number K192123.

Who is the listed applicant for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

The FDA 510(k) record lists Qingdao Hightop Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream?

The FDA product code for HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream is LCX.

列明Qingdao Hightop Biotech Co., Ltd.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。

K241969Hightop®家用芬太尼/诺芬太尼尿液快速测试板；Hightop®芬太尼/诺芬太尼尿液快速测试板 K220685HIGHTOP 多药物尿液测试杯，HIGHTOP 多药物尿液测试杯 Rx

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.

官方来源

在 FDA 数据库中查看 →

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。