Health Diagnostics Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Health Diagnostics Corp. makes
Health Diagnostics Corp. manufactures blood gas control products, including calibration and verification sets (BG-1, BG-2), and an in-home early pregnancy test kit designed for point-of-care use.
The company’s portfolio includes Class I and Class II devices, all of which are listed via FDA 510(k) clearance. The manufacturer is based in the United States.
Catalogue
Blood Gas Control Prod. No. Bg-1, Bg-2 Ref K801449
Regimes: 510(k) Registry: 510(k)In-Home Early Pregnancy Test Kit Ref K802334
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Health Diagnostics Corp. have in the registry?
The registry currently lists 2 devices for Health Diagnostics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Health Diagnostics Corp.'s devices?
Among its 2 most recently registered devices, Health Diagnostics Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Health Diagnostics Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Health Diagnostics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Health Diagnostics Corp. in the registry?
The most recently registered devices listed for Health Diagnostics Corp. include BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 and IN-HOME EARLY PREGNANCY TEST KIT.