T2生物威胁检测板
K号: K231336 · 2023-09-15
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决定日期2023-09-15
产品代码QVR
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器械摘要
T2 Biothreat Panel is the device name listed in this FDA 510(k) record. The listed applicant is T2biosystems, Inc.. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K231336. The device is classified under product code QVR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the T2 Biothreat Panel?
T2 Biothreat Panel is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is T2biosystems, Inc.. The 510(k) number is K231336.
When did T2 Biothreat Panel receive FDA 510(k) clearance?
T2 Biothreat Panel received FDA 510(k) clearance on 2023-09-15, under 510(k) number K231336.
Who is the listed applicant for T2 Biothreat Panel?
The FDA 510(k) record lists T2biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for T2 Biothreat Panel?
The FDA product code for T2 Biothreat Panel is QVR.
相关临床试验
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列明T2biosystems, 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：QVR）
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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