Roche
Country not established
- Devices
- 3
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Homocysteine Test Ref K113793
Regimes: 510(k) Registry: 510(k)Tq HBA1C GEN3 Ref K102914
Regimes: 510(k) Registry: 510(k)cobas EGFR Mutation Test v2 Ref P120019
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Roche have in the registry?
The registry currently lists 3 devices for Roche. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche's devices?
Among its 3 most recently registered devices, Roche has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Roche's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Roche's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Roche in the registry?
The most recently registered devices listed for Roche include HOMOCYSTEINE TEST, TQ HBA1C GEN3 and cobas EGFR Mutation Test v2.