FDA 510(k)

T2Candida 1.1 Panel

K号: K173536 · 2017-12-12

决定日期2017-12-12

产品代码PII

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决定实质等同

器械摘要

T2Candida 1.1 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 2017-12-12 under 510(k) number K173536. The device is classified under product code PII. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the T2Candida 1.1 Panel?

T2Candida 1.1 Panel is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is T2biosystems, Inc.. The 510(k) number is K173536.

When did T2Candida 1.1 Panel receive FDA 510(k) clearance?

T2Candida 1.1 Panel received FDA 510(k) clearance on 2017-12-12, under 510(k) number K173536.

Who is the listed applicant for T2Candida 1.1 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 T2Candida 1.1 Panel?

The FDA product code for T2Candida 1.1 Panel is PII.

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。

K234063T2Candida 1.1 Panel K233184T2Bacteria® Panel K231336T2生物威胁检测板 K172708T2Bacteria Panel

官方来源

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