STA Satellite Max®
K号: K253658 · 2026-04-27
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决定日期2026-04-27
产品代码JPA
咨询委员会HE
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器械摘要
STA Satellite Max® is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K253658. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the STA Satellite Max®?
STA Satellite Max® is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K253658.
When did STA Satellite Max® receive FDA 510(k) clearance?
STA Satellite Max® received FDA 510(k) clearance on 2026-04-27, under 510(k) number K253658.
Who is the listed applicant for STA Satellite Max®?
FDA 510(k)记录将Diagnostica Stago, Inc.列为申请人。这本身并不能确立该设备的制造商。
What is the FDA product code for STA Satellite Max®?
The FDA product code for STA Satellite Max® is JPA.
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。
列明Diagnostica Stago, Inc.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。
相关器械（代码：JPA）
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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