510(k) K030144

MODIFICATION TO PENTRA 60 AND PENTRA 60C+ by Abx Diagnostics — Product Code GKZ

K030144 is an FDA 510(k) premarket notification submitted by Abx Diagnostics for the device "MODIFICATION TO PENTRA 60 AND PENTRA 60C+". The FDA issued a decision of Substantially Equivalent on January 31, 2003. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Abx Diagnostics has at least 9 other 510(k) clearances on record.