510(k) K092570

ABX PENTRA TPU CAL, MODEL A11A01898 by HORIBA ABX SAS — Product Code JIT

K092570 is an FDA 510(k) premarket notification submitted by HORIBA ABX SAS for the device "ABX PENTRA TPU CAL, MODEL A11A01898". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. HORIBA ABX SAS has at least 10 other 510(k) clearances on record.