Columbia Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Accuracy Ref K854119
Regimes: 510(k) Registry: 510(k)Quality Control Material (Assayed) Ref K935819
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Columbia Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Columbia Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Columbia Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Columbia Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Columbia Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Columbia Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Columbia Diagnostics, Inc. in the registry?
The most recently registered devices listed for Columbia Diagnostics, Inc. include ACCURACY and QUALITY CONTROL MATERIAL (ASSAYED).