Serono Baker Diagnostics System
Country not established
- Devices
- 1
What Serono Baker Diagnostics System makes
Serono Baker Diagnostics System manufactures the SYSTEM 9000, an interpretive differential cell counter designed for hematological analysis in clinical laboratories. This device automates the counting and classification of white blood cells, red blood cells, and platelets, providing diagnostic support for conditions such as infections, anemia, and leukemia.
The SYSTEM 9000 is classified as a Class II medical device under FDA regulations and is listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
System 9000, Interpretive Diff Cell Counter Ref K911626
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Serono Baker Diagnostics System have in the registry?
The registry currently lists 1 device for Serono Baker Diagnostics System. Devices recorded under merged duplicate company entries are counted once.
Which registries list Serono Baker Diagnostics System's devices?
Among its 1 most recently registered device, Serono Baker Diagnostics System has devices listed in FDA 510(k) (1 device).
What risk classes do Serono Baker Diagnostics System's devices fall under?
Among its 1 most recently registered device, the classes recorded for Serono Baker Diagnostics System's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Serono Baker Diagnostics System in the registry?
The most recently registered devices listed for Serono Baker Diagnostics System include SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER.