Roche Diagnostics Operations FDA Approvals

0 new drug approvals and 2 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
Tina-quant Lipoprotein(a) Gen.2 Molarity510(k)Jan 24, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jan 24, 2025
ONLINE TDM Methotrexate510(k)Feb 20, 2024	—	510(k)Substantially Equivalent (Traditional)	Feb 20, 2024