Abaxis Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
20
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2361-2020Class IIPiccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II)December 11, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K200865Piccolo Potassium Test SystemOctober 20, 2021
K130113PICCOLO LACTATE TEST SYSTEMMarch 11, 2013
K130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMFebruary 15, 2013
K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMApril 24, 2012
K120662PICCOLO HDL-CAPILLARY TEST SYSTEMApril 24, 2012
K091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMJanuary 15, 2010
K091910PICCOLO MAGNESIUM TEST SYSTEMOctober 1, 2009
K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMJuly 8, 2005
K040115PICCOLO MAGNESIUM TEST SYSTEMJanuary 30, 2004
K023642PICCOLO TOTAL CHOLESTEROL TEST SYSTEMJanuary 24, 2003
K023640PICCOLO HDL TEST SYSTEMJanuary 24, 2003
K023639PICCOLO TRIGLYCERIDES TEST SYSTEMJanuary 24, 2003
K022312PICCOLO PHOSPHORUS TEST SYSTEMSeptember 5, 2002
K010670PICCOLO CHLORIDE TEST SYSTEMApril 26, 2001
K993211PICCOLO SODIUM TEST SYSTEMOctober 25, 1999
K992140PICCOLO METLYTE 7 REAGENT DISCAugust 26, 1999
K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMSeptember 9, 1996
K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORApril 13, 1995
K942782PICCOLO(TM)March 13, 1995
K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORApril 6, 1994