T2biosystems, Inc. - FDA 510(k) Cleared Devices

T2 Biosystems, Inc. was an in vitro diagnostics company formerly based in Lexington, Massachusetts. The company is no longer operating and has completed winding down of operations.

During its active period, T2 Biosystems received 5 FDA 510(k) clearances from 6 total submissions. The company specialized exclusively in Microbiology devices, with its first clearance in 2014 and most recent clearance in 2024. This regulatory track record reflects the company's focus on rapid diagnostic solutions for infectious disease detection.

For inquiries regarding T2 Biosystems' cleared devices, product codes, and clearance dates, contact T2@vlpc.com or visit the company's correspondence address at 124 Washington Street, Suite 101, Foxboro, MA 02035.