Sunquest Intl., Inc.
TaiwanFDA applicant, unverified
- Devices
- 1
What Sunquest Intl., Inc. makes
Sunquest International manufactures laboratory information management systems, including software solutions for hospital and clinical laboratory workflows. These systems integrate patient data, test results, and reporting functionalities to streamline diagnostic processes and improve operational efficiency in healthcare settings.
The company’s portfolio is regulated under the FDA’s Class I device classification, with relevant products authorised via the 510(k) clearance pathway. These systems are listed in the FDA’s regulatory database, adhering to U.S. medical device compliance standards.
Catalogue
Sunquest International Ref K963059
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sunquest Intl., Inc. have in the registry?
The registry currently lists 1 device for Sunquest Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sunquest Intl., Inc.'s devices?
Among its 1 most recently registered device, Sunquest Intl., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Sunquest Intl., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sunquest Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sunquest Intl., Inc. in the registry?
The most recently registered devices listed for Sunquest Intl., Inc. include SUNQUEST INTERNATIONAL.