Home » FDA Clears EKF’s Hemoglobin Analyzer
FDA Clears EKF’s Hemoglobin Analyzer
Devices Submissions and Approvals
The FDA granted 510(k) clearance to EKF Diagnostics’ Diaspect Tm POC hand-held, reagent-free hemoglobin analyzer.
The device requires minimal training and it is always on, with no maintenance or calibration required.
The device gives users accurate hemoglobin measurements within two seconds of insertion for analysis. It can be used in a variety of settings as well as by a wide range of health care personnel.