Diagnostic Corp. of America
United StatesFDA applicant, unverified
- Devices
- 3
What Diagnostic Corp. of America makes
Diagnostic Corp. of America produces in vitro diagnostic tests for measuring iron metabolism, thyroid function, and cardiac markers. Their portfolio includes assays for total iron binding capacity, radioimmunoassay (RIA) tests for thyroid-stimulating hormone (TSH) in human serum or plasma, and RIA-based digoxin measurements.
These devices are regulated under FDA’s 510(k) pathway and fall into Class I and Class II categories. The company’s products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Total Iron Binding Capacity Ref K780412
Regimes: 510(k) Registry: 510(k)Ria Tsh In Human Serum Or Plasma Ref K781150
Regimes: 510(k) Registry: 510(k)Dca Digox-Syn Ria Test Ref K810477
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnostic Corp. of America have in the registry?
The registry currently lists 3 devices for Diagnostic Corp. of America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostic Corp. of America's devices?
Among its 3 most recently registered devices, Diagnostic Corp. of America has devices listed in FDA 510(k) (3 devices).
What risk classes do Diagnostic Corp. of America's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diagnostic Corp. of America's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnostic Corp. of America in the registry?
The most recently registered devices listed for Diagnostic Corp. of America include TOTAL IRON BINDING CAPACITY, RIA TSH IN HUMAN SERUM OR PLASMA and DCA DIGOX-SYN RIA TEST.