Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

T2Candida 1.1 Panel

K-Number: K234063 · 2024-09-13

ApplicantT2biosystems, Inc.
Decision Date2024-09-13
Product CodePII
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

T2Candida 1.1 Panel is a medical device manufactured by T2biosystems, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval 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. It is manufactured by T2biosystems, Inc.. The 510(k) number is K234063.

When was T2Candida 1.1 Panel approved by the FDA?

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

What company makes T2Candida 1.1 Panel?

T2Candida 1.1 Panel is manufactured by T2biosystems, Inc..

What is the FDA product code for T2Candida 1.1 Panel?

The FDA product code for T2Candida 1.1 Panel is PII.

Other Devices by T2biosystems, Inc.

K173536T2Candida 1.1 Panel K172708T2Bacteria Panel K231336T2 Biothreat Panel K233184T2Bacteria® Panel

Related Devices (Code: PII)

K173536T2Candida 1.1 PanelT2biosystems, Inc.

Official Source

View on FDA Database →

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

↑