Medcom Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Medcom Diagnostics, Inc. makes
Medcom Diagnostics, Inc. manufactures thyroid function test kits, including the THYRODOT-4 and THYRODOT-SH for detecting thyroid hormones, as well as the THYRODOT-4 Antisera Lyophilized for reagent use in diagnostic assays.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Thyrodot-4, Thyrodot-Sh Ref K771377
Regimes: 510(k) Registry: 510(k)Thyrodot-4 Antisera Lyopholized Ref K772064
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medcom Diagnostics, Inc. have in the registry?
The registry currently lists 2 devices for Medcom Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medcom Diagnostics, Inc.'s devices?
Among its 2 most recently registered devices, Medcom Diagnostics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medcom Diagnostics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medcom Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medcom Diagnostics, Inc. in the registry?
The most recently registered devices listed for Medcom Diagnostics, Inc. include THYRODOT-4, THYRODOT-SH and THYRODOT-4 ANTISERA LYOPHOLIZED.