Roche Diabetes Care, Inc. FDA Approvals

0 new drug approvals and 7 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 Safe-T-Pro Plus Lancing Device510(k)Nov 13, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device510(k)Nov 13, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device510(k)May 19, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 19, 2022
IWL2020 Blood Glucose Monitoring System510(k)May 6, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 6, 2022
Accu-Chek FastClix Blood Lancing System510(k)Apr 29, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 29, 2022
Accu-Chek Safe-T-Pro Uno Lancing Device510(k)Apr 5, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Apr 5, 2022
Accu-Chek Softclix Blood Lancing System510(k)Feb 17, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 17, 2022