MBT Sepsityper
K号: K193419 · 2020-12-27
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决定日期2020-12-27
产品代码QNJ
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器械摘要
MBT Sepsityper is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonik GmbH. It received FDA 510(k) clearance on 2020-12-27 under 510(k) number K193419. The device is classified under product code QNJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MBT Sepsityper?
MBT Sepsityper is a medical device that received FDA 510(k) clearance on 2020-12-27. The listed applicant is Bruker Daltonik GmbH. The 510(k) number is K193419.
When did MBT Sepsityper receive FDA 510(k) clearance?
MBT Sepsityper received FDA 510(k) clearance on 2020-12-27, under 510(k) number K193419.
Who is the listed applicant for MBT Sepsityper?
The FDA 510(k) record lists Bruker Daltonik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MBT Sepsityper?
The FDA product code for MBT Sepsityper is QNJ.
相关临床试验
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列明Bruker Daltonik GmbH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：QNJ）
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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