510(k) K071562

D3 HEMATOLOGY ANALYZER, MODEL D3 by Drew Scientific, Inc. — Product Code GKZ

K071562 is an FDA 510(k) premarket notification submitted by Drew Scientific, Inc. for the device "D3 HEMATOLOGY ANALYZER, MODEL D3". The FDA issued a decision of Substantially Equivalent on December 11, 2007. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Drew Scientific, Inc. has at least 8 other 510(k) clearances on record.