#Industry News
EKF secures FDA clearance for DiaSpect Tm POC hemoglobin analyzer
Easy to use, reagent-free analyzer cleared for use in POC & CLIA waived settings
EKF Diagnostics announces U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver for the Company’s hand-held, reagent-free hemoglobin analyzer, the DiaSpect Tm. The device is cleared for use in point of care (POC) and Certificate of Waiver settings, such as physicians’ offices, clinics and other non-traditional laboratory locations.