SpermAlign 精子分离装置
K号: K232980 · 2024-03-14
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决定日期2024-03-14
产品代码MQK
咨询委员会OB
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决定实质等同
器械摘要
SpermAlign Sperm Separation Device is the device name listed in this FDA 510(k) record. The listed applicant is Cytoswim, Ltd.. It received FDA 510(k) clearance on 2024-03-14 under 510(k) number K232980. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SpermAlign Sperm Separation Device?
SpermAlign Sperm Separation Device is a medical device that received FDA 510(k) clearance on 2024-03-14. The listed applicant is Cytoswim, Ltd.. The 510(k) number is K232980.
When did SpermAlign Sperm Separation Device receive FDA 510(k) clearance?
SpermAlign Sperm Separation Device received FDA 510(k) clearance on 2024-03-14, under 510(k) number K232980.
Who is the listed applicant for SpermAlign Sperm Separation Device?
The FDA 510(k) record lists Cytoswim, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SpermAlign Sperm Separation Device?
The FDA product code for SpermAlign Sperm Separation Device is MQK.
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。
相关器械（代码：MQK）
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。
K241626SperSort™ 精子分离芯片（IPG02）Ipreg IncorporationK241454Minvitro® 玻璃化吸管 (MVT-VSN 系列，包括 MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® 收割器（1 mL）；SwimCount® 收割器（3 mL）Motilitycount ApsK241341cryo-GO 冷冻玻璃化设备Fujifilm Irvine ScientificK240002G-Vitri™玻璃化吸管Gimbo Medical Technology Shenzhen Co., Ltd.K233177Nest VT 液化设备Cook Incorporated
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。
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