Source document or public record
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.
Source
"device_name": "T2 Biothreat Panel"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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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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