510(k) K022200

PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 by Abx Diagnostics — Product Code GKZ

K022200 is an FDA 510(k) premarket notification submitted by Abx Diagnostics for the device "PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120". The FDA issued a decision of Substantially Equivalent on July 29, 2002. 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.