Mec Dynamics Corp
United StatesFDA applicant, unverified
- Devices
- 4
What Mec Dynamics Corp makes
Mec Dynamics Corp manufactures in vitro diagnostic devices for hemoglobin (Hb) and glycated hemoglobin (A1C) testing, including the AVIE TOTAL HB TEST SYSTEM and the AVIE A1C TEST SYSTEM, along with modifications to the A1C system.
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
Avie Total Hb Test System Ref K121752
Regimes: 510(k) Registry: 510(k)Avie A1C Test System Ref K093548
Regimes: 510(k) Registry: 510(k)Avie A1C Test System Ref K081269
Regimes: 510(k) Registry: 510(k)Modification To Avie A1C Test System Ref K091400
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Mec Dynamics Corp have in the registry?
The registry currently lists 4 devices for Mec Dynamics Corp. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mec Dynamics Corp's devices?
Among its 4 most recently registered devices, Mec Dynamics Corp has devices listed in FDA 510(k) (4 devices).
What risk classes do Mec Dynamics Corp's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Mec Dynamics Corp's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mec Dynamics Corp in the registry?
The most recently registered devices listed for Mec Dynamics Corp include AVIE TOTAL HB TEST SYSTEM, AVIE A1C TEST SYSTEM and MODIFICATION TO AVIE A1C TEST SYSTEM.