SperSort™ 精子分离芯片（IPG02）
K号: K241626 · 2025-02-20
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决定日期2025-02-20
产品代码MQK
咨询委员会OB
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器械摘要
SperSort™ Sperm Sorting Chip (IPG02) is the device name listed in this FDA 510(k) record. The listed applicant is Ipreg Incorporation. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K241626. 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 SperSort™ Sperm Sorting Chip (IPG02)?
SperSort™ Sperm Sorting Chip (IPG02) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Ipreg Incorporation. The 510(k) number is K241626.
When did SperSort™ Sperm Sorting Chip (IPG02) receive FDA 510(k) clearance?
SperSort™ Sperm Sorting Chip (IPG02) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K241626.
Who is the listed applicant for SperSort™ Sperm Sorting Chip (IPG02)?
The FDA 510(k) record lists Ipreg Incorporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SperSort™ Sperm Sorting Chip (IPG02)?
The FDA product code for SperSort™ Sperm Sorting Chip (IPG02) 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。
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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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