Coulter Electronics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 101
What Coulter Electronics, Inc. makes
Coulter Electronics, Inc. manufactures in vitro diagnostic devices for hematology and clinical chemistry, including automated cell counters, differential leukocyte analyzers, and reagent systems for measuring platelet volume, cholesterol, HDL cholesterol, and phenytoin levels. Their portfolio also includes specialized calibrators and immunoassay reagents for laboratory use.
The company’s devices are classified under FDA’s Class I and Class II categories, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory clearance in the United States.
Catalogue
Search and filter all 101 devicesShowing 1-50 of 101
Frequently asked questions
How many devices does Coulter Electronics, Inc. have in the registry?
The registry currently lists 101 devices for Coulter Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coulter Electronics, Inc.'s devices?
Among its 50 most recently registered devices, Coulter Electronics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Coulter Electronics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Coulter Electronics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Coulter Electronics, Inc. in the registry?
The most recently registered devices listed for Coulter Electronics, Inc. include COULTER RETIC-C CELL CONTROL, COULTER URIC ACID REAGENT, COULTER DIRECT BILLRUBIN REAGENT and COULTER COUNTER-BLOOD CELL COUNTER.