Compliance Consultants has submitted Class II for automated hematology analyzers that diagnose a multitude of blood parameters using prepared regents. These systems use automatically prepared samples for the acquisition of blood samples and and analysis. This assists the physician in diagnosing patient blood samples and reports various concentrations or counts of whole blood.


This instrument withdraws samples from a cassette, adds blood and reagents into daughter tubes, and mixes the sample according to preprogrammed or custom protocols for analysis.


Whole Blood and Differential Cell Counters, Hematology analyzers. Regulation Number: 21 CFR Part 864.5220, Product Code:GKZ