Abaxis Inc
FDA Regulatory Profile
Abaxis Inc appears in FDA public data with 1 recall, 20 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2361-2020, Class II) was initiated on December 11, 2019. Its most recent 510(k) clearance was granted on October 20, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 20
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2361-2020 | Class II | Piccolo 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-Number | Device | Date |
|---|
| K200865 | Piccolo Potassium Test System | October 20, 2021 |
| K130113 | PICCOLO LACTATE TEST SYSTEM | March 11, 2013 |
| K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM | February 15, 2013 |
| K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM | April 24, 2012 |
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | April 24, 2012 |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | January 15, 2010 |
| K091910 | PICCOLO MAGNESIUM TEST SYSTEM | October 1, 2009 |
| K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | July 8, 2005 |
| K040115 | PICCOLO MAGNESIUM TEST SYSTEM | January 30, 2004 |
| K023639 | PICCOLO TRIGLYCERIDES TEST SYSTEM | January 24, 2003 |
| K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM | January 24, 2003 |
| K023640 | PICCOLO HDL TEST SYSTEM | January 24, 2003 |
| K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | September 5, 2002 |
| K010670 | PICCOLO CHLORIDE TEST SYSTEM | April 26, 2001 |
| K993211 | PICCOLO SODIUM TEST SYSTEM | October 25, 1999 |
| K992140 | PICCOLO METLYTE 7 REAGENT DISC | August 26, 1999 |
| K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM | September 9, 1996 |
| K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR | April 13, 1995 |
| K942782 | PICCOLO(TM) | March 13, 1995 |
| K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | April 6, 1994 |