离子PGM Dx系统
K号: K170299 · 2017-06-22
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决定日期2017-06-22
产品代码PFF
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器械摘要
Ion PGM Dx System is the device name listed in this FDA 510(k) record. The listed applicant is Life Technologies Corporation. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K170299. The device is classified under product code PFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ion PGM Dx System?
Ion PGM Dx System is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Life Technologies Corporation. The 510(k) number is K170299.
When did Ion PGM Dx System receive FDA 510(k) clearance?
Ion PGM Dx System received FDA 510(k) clearance on 2017-06-22, under 510(k) number K170299.
Who is the listed applicant for Ion PGM Dx System?
The FDA 510(k) record lists Life Technologies Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ion PGM Dx System?
The FDA product code for Ion PGM Dx System is PFF.
相关临床试验
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列明Life Technologies Corporation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。
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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