Apo Diagnostics, Inc.
CanadaFDA applicant, unverified
- Devices
- 1
What Apo Diagnostics, Inc. makes
Apo Diagnostics, Inc. manufactures the Cariescreen LB, a diagnostic device used for detecting dental caries (tooth decay) in children and adults. This handheld device provides a rapid, non-invasive test to identify early signs of cavities by analyzing saliva samples.
The company’s portfolio is regulated under Class I medical devices in the United States, with the Cariescreen LB authorised through the FDA’s 510(k) clearance process. The device is listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for Class I diagnostic tools.
Catalogue
Cariescreen Lb Ref K871264
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apo Diagnostics, Inc. have in the registry?
The registry currently lists 1 device for Apo Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apo Diagnostics, Inc.'s devices?
Among its 1 most recently registered device, Apo Diagnostics, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Apo Diagnostics, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Apo Diagnostics, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Apo Diagnostics, Inc. in the registry?
The most recently registered devices listed for Apo Diagnostics, Inc. include CARIESCREEN LB.