Jk Research
Country not established
- Devices
- 1
What Jk Research makes
Jk Research manufactures the ACCUSCREEN ASSAY, a diagnostic device designed for rapid point-of-care testing of specific biomarkers in blood or serum samples. This assay is intended for use in clinical settings to aid in the detection and monitoring of conditions requiring precise analytical results.
The ACCUSCREEN ASSAY is classified as a Class II medical device under FDA regulations and has undergone 510(k) clearance. The company is based in the United States, where its products are registered and subject to compliance with U.S. medical device regulations.
Catalogue
Accuscreen Assay Ref K920018
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Jk Research have in the registry?
The registry currently lists 1 device for Jk Research. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jk Research's devices?
Among its 1 most recently registered device, Jk Research has devices listed in FDA 510(k) (1 device).
What risk classes do Jk Research's devices fall under?
Among its 1 most recently registered device, the classes recorded for Jk Research's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jk Research in the registry?
The most recently registered devices listed for Jk Research include ACCUSCREEN ASSAY.