Earlitec Diagnostics
Also registered as Earlitec Diagnostics, Inc.
Country not established FDA establishment FEI 3027553518
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- GUDID
EarliPoint Ref K230337
510(k) 510(k)EarliPoint Assessment Ref K253442
510(k) 510(k)EarliPoint System Ref K213882
510(k) 510(k)EarliPoint System Ref K243891
510(k) 510(k)
Company details
- FDA FEI number
- 3027553518
- Address
- 13895 Industrial Park Blvd Ste 140, Plymouth, MN, 55441
Frequently asked questions
How many devices does EARLITEC DIAGNOSTICS have in the registry?
The registry currently lists 5 devices for EARLITEC DIAGNOSTICS. Devices recorded under merged duplicate company entries are counted once.
Which registries list EARLITEC DIAGNOSTICS's devices?
Among its 5 most recently registered devices, EARLITEC DIAGNOSTICS has devices listed in FDA 510(k) (4 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EARLITEC DIAGNOSTICS's devices fall under?
Among its 5 most recently registered devices, the classes recorded for EARLITEC DIAGNOSTICS's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from EARLITEC DIAGNOSTICS in the registry?
The most recently registered devices listed for EARLITEC DIAGNOSTICS include EarliPoint EPT001, EarliPoint, EarliPoint Assessment and EarliPoint System.