Opko Health, Inc.
Country not established
- Devices
- 2
What Opko Health, Inc. makes
Opko Health, Inc. manufactures the SPECTRAL OCT/SLO, a combined optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) system for retinal imaging, and the 4Kscore Test, a molecular diagnostic assay for prostate cancer risk assessment.
The company’s portfolio includes devices regulated as Class II and Class III under FDA authorities, with products authorised via 510(k) clearances and Premarket Approval Applications (PMA). These devices are listed in the FDA’s regulatory databases.
Catalogue
Spectral Oct/Slo Ref K080460
Regimes: 510(k) Registry: 510(k)4Kscore Test Ref P190022
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Opko Health, Inc. have in the registry?
The registry currently lists 2 devices for Opko Health, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opko Health, Inc.'s devices?
Among its 2 most recently registered devices, Opko Health, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Opko Health, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Opko Health, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Opko Health, Inc. in the registry?
The most recently registered devices listed for Opko Health, Inc. include SPECTRAL OCT/SLO and 4Kscore Test.