T2biosystems, Inc.
Lexington, MA, US
T2biosystems, Inc. appears in FDA device records in Lexington, MA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 6
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 6 510(k) clearances for T2biosystems, Inc. between 2014 and 2024. The busiest year on record is 2024, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K234063 | T2Candida 1.1 Panel | PII | Substantially Equivalent | |
| K233184 | T2Bacteria® Panel | QBX | Substantially Equivalent | |
| K231336 | T2 Biothreat Panel | QVR | Substantially Equivalent | |
| K172708 | T2Bacteria Panel | QBX | Substantially Equivalent | |
| K173536 | T2Candida 1.1 Panel | PII | Substantially Equivalent | |
| DEN140019 | T2CANDIDA AND T2DX INSTRUMENT | PII | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain