免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

WHOLEPOWER 孕检快速测试条，WHOLEPOWER 孕检快速测试卡，WHOLEPOWER 孕检快速测试中段条

K号: K190705 · 2019-04-15

申请人Wholepower Biotech Co., Ltd.
决定日期2019-04-15
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

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Wholepower Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K190705. 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 WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream?

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Wholepower Biotech Co., Ltd.. The 510(k) number is K190705.

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

WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream received FDA 510(k) clearance on 2019-04-15, under 510(k) number K190705.

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

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

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

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

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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., LLCK242135Synthgene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., LLCK241394iHealth® 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。

↑