真诊断系统
K号: K183530 · 2019-05-24
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决定日期2019-05-24
产品代码ODW
咨询委员会TX
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决定实质等同
器械摘要
TruDiagnosis System is the device name listed in this FDA 510(k) record. The listed applicant is Akonni Biosystems, Inc.. It received FDA 510(k) clearance on 2019-05-24 under 510(k) number K183530. The device is classified under product code ODW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TruDiagnosis System?
TruDiagnosis System is a medical device that received FDA 510(k) clearance on 2019-05-24. The listed applicant is Akonni Biosystems, Inc.. The 510(k) number is K183530.
When did TruDiagnosis System receive FDA 510(k) clearance?
TruDiagnosis System received FDA 510(k) clearance on 2019-05-24, under 510(k) number K183530.
Who is the listed applicant for TruDiagnosis System?
The FDA 510(k) record lists Akonni Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TruDiagnosis System?
The FDA product code for TruDiagnosis System is ODW.
相关临床试验
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相关器械（代码：ODW）
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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