Abbott Diagnostics Mfg., Inc.
Country not established
- Devices
- 1
What Abbott Diagnostics Mfg., Inc. makes
Abbott Diagnostics Mfg., Inc. produces automated chemistry analyzers, including the ACP series, designed for clinical laboratory testing of blood and serum samples to measure electrolytes, glucose, and other biochemical parameters.
These devices are regulated as Class II under the FDA’s 510(k) clearance process and are listed in the U.S. regulatory database. The manufacturer is based in the United States.
Catalogue
Acp Ref K991010
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Abbott Diagnostics Mfg., Inc. have in the registry?
The registry currently lists 1 device for Abbott Diagnostics Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Diagnostics Mfg., Inc.'s devices?
Among its 1 most recently registered device, Abbott Diagnostics Mfg., Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Abbott Diagnostics Mfg., Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Abbott Diagnostics Mfg., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abbott Diagnostics Mfg., Inc. in the registry?
The most recently registered devices listed for Abbott Diagnostics Mfg., Inc. include ACP.