Diamond Shamrock Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Diamond Shamrock Corp. makes
Diamond Shamrock Corp. manufactures a transcutaneous blood oxygen sensor system for non-invasive monitoring of oxygen levels in patients, as well as a radioassay kit for measuring folate levels using the radioactive isotope ³H. These devices support clinical diagnostics and metabolic assessments.
The company’s portfolio consists of Class II medical devices, which are regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, ensuring compliance with U.S. regulatory requirements. The company is headquartered in the United States.
Catalogue
Transcutaneous Blood Oxygen Sensor Sys Ref K830197
Regimes: 510(k) Registry: 510(k)Radioassy Kit, 3H-Folate Ref K760262
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diamond Shamrock Corp. have in the registry?
The registry currently lists 2 devices for Diamond Shamrock Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diamond Shamrock Corp.'s devices?
Among its 2 most recently registered devices, Diamond Shamrock Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Diamond Shamrock Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Diamond Shamrock Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diamond Shamrock Corp. in the registry?
The most recently registered devices listed for Diamond Shamrock Corp. include TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS and RADIOASSY KIT, 3H-FOLATE.