Omics Core
K号: K190661 · 2019-11-09
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决定日期2019-11-09
产品代码PZM
咨询委员会PA
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决定实质等同
器械摘要
Omics Core is the device name listed in this FDA 510(k) record. The listed applicant is Nanthealth, Inc.. It received FDA 510(k) clearance on 2019-11-09 under 510(k) number K190661. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Omics Core?
Omics Core is a medical device that received FDA 510(k) clearance on 2019-11-09. The listed applicant is Nanthealth, Inc.. The 510(k) number is K190661.
When did Omics Core receive FDA 510(k) clearance?
Omics Core received FDA 510(k) clearance on 2019-11-09, under 510(k) number K190661.
Who is the listed applicant for Omics Core?
The FDA 510(k) record lists Nanthealth, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omics Core?
The FDA product code for Omics Core is PZM.
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相关器械（代码：PZM）
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
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