Documento fuente o registro público

FDA 510(k) K231336 — T2 Biothreat Panel

FDA 510(k) index record K231336. Device: T2 Biothreat Panel. Applicant as listed: T2biosystems, Inc.. Decision date: 2023-09-15.

OtherU.S. Food and Drug Administration (FDA)2023-09-15

Fuente

"device_name": "T2 Biothreat Panel"
api.fda.gov · Consultado el 2026-10-27

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

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Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-28

Disclaimer

professional use

References

FDA 510(k) public index record K231336.

Device name: T2 Biothreat Panel. Applicant as listed: T2biosystems, Inc..

Decision date: 2023-09-15. Decision wording: Substantially Equivalent.

Product code: QVR. Regulation: 21 CFR 866.4000. Medical specialty: Immunology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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FDA 510(k) K231336 — T2 Biothreat Panel

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