Coulter Electronics, Inc.

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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.