Roche Diabetes Care GmbH 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
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system510(k)Aug 10, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology510(k)Aug 10, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 10, 2023