FDA 510(k)

T2Candida 1.1 Panel

K-Number: K234063 · 2024-09-13

Decision Date2024-09-13

Product CodePII

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

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 2024-09-13 under 510(k) number K234063. The device is classified under product code PII. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2Candida 1.1 Panel?

T2Candida 1.1 Panel is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is T2biosystems, Inc.. The 510(k) number is K234063.

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

T2Candida 1.1 Panel received FDA 510(k) clearance on 2024-09-13, under 510(k) number K234063.

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.

Other records listing T2biosystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233184T2Bacteria® Panel K231336T2 Biothreat Panel K172708T2Bacteria Panel K173536T2Candida 1.1 Panel

Related Devices (Code: PII)

K173536T2Candida 1.1 PanelT2biosystems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.