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FDA 510(k)

Atlas One Step hCG 尿妊娠测试（条），Atlas One Step hCG 尿妊娠测试（卡式），Atlas One Step hCG 尿妊娠测试（中段）

K号: K203246 · 2021-08-04

申请人Atlas Link Technology Co., Ltd.
决定日期2021-08-04
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

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) is the device name listed in this FDA 510(k) record. The listed applicant is Atlas Link Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K203246. 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 Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)?

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Atlas Link Technology Co., Ltd.. The 510(k) number is K203246.

When did Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) receive FDA 510(k) clearance?

Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) received FDA 510(k) clearance on 2021-08-04, under 510(k) number K203246.

Who is the listed applicant for Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)?

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

What is the FDA product code for Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)?

The FDA product code for Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy 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

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