510(k) K071652

HEMOCUE WBC SYSTEM by Hemocue AB — Product Code GKL

K071652 is an FDA 510(k) premarket notification submitted by Hemocue AB for the device "HEMOCUE WBC SYSTEM". The FDA issued a decision of Substantially Equivalent on October 25, 2007. The device falls under product code GKL (Counter, Cell, Automated (Particle Counter)), a Class II device regulated under 21 CFR 864.5200. Hemocue AB has at least 10 other 510(k) clearances on record.