T2biosystems, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
T2Candida 1.1 Panel510(k)Sep 13, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Sep 13, 2024
T2Bacteria® Panel510(k)Feb 8, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Feb 8, 2024
T2 Biothreat Panel510(k)Sep 15, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023