Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list T2biosystems, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Sep 13, 2024: T2Candida 1.1 Panel.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 13, 2024 | T2Candida 1.1 PanelK234063 · PII | 510(k) clearances |
| Feb 8, 2024 | T2Bacteria® PanelK233184 · QBX | 510(k) clearances |
| Sep 15, 2023 | T2 Biothreat PanelK231336 · QVR | 510(k) clearances |
| May 24, 2018 | T2Bacteria PanelK172708 · QBX | 510(k) clearances |
| Dec 12, 2017 | T2Candida 1.1 PanelK173536 · PII | 510(k) clearances |
| Sep 22, 2014 | T2CANDIDA AND T2DX INSTRUMENTDEN140019 · PII | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
