Abaxis, Inc.
Medical device manufacturer in Union City, CA.
20510(k) clearances
0PMA approvals
5recalls
Device types
- CHH Enzymatic Esterase--Oxidase, Cholesterol 3
- JJG Analyzer, Chemistry, Centrifugal, For… 2
- JGY Colorimetric Method, Triglycerides 2
- JGJ Photometric Method, Magnesium 2
- JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 1
- JLB Atp And Creatine Kinase (Enzymatic), Creatine 1
- JGS Electrode, Ion Specific, Sodium 1
- CHJ Mercuric Thiocyanate, Colorimetry, Chloride 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- DCN System, Test, C-Reactive Protein 1
- JHM Colorimetric Method, Lipoproteins 1
- KHP Acid, Lactic, Enzymatic Method 1
- MZV Test, System, Potassium, Enzymatic Method 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K200865 | Piccolo Potassium Test SystemMZV · Dual Track | 10/20/2021SE |
| K130113 | Piccolo Lactate Test SystemKHP · Traditional | 03/11/2013SE |
| K130200 | Piccolo Total Cholesterol - Capillary Test SystemCHH · Traditional | 02/15/2013SE |
| K120664 | Piccolo Trglycerides-Capillary Test SystemJGY · Traditional | 04/24/2012SE |
| K120662 | Piccolo Hdl-Capillary Test SystemJHM · Traditional | 04/24/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | 01/15/2010SE |
| K091910 | Piccolo Magnesium Test SystemJGJ · Special | 10/01/2009SE |
| K051108 | Piccolo Lactate Dephydrogenase Test SystemCFJ · Traditional | 07/08/2005SE |
| K040115 | Piccolo Magnesium Test SystemJGJ · Traditional | 01/30/2004SE |
| K023642 | Piccolo Total Cholesterol Test SystemCHH · Traditional | 01/24/2003SE |
| K023640 | Piccolo HDL Test SystemLBS · Traditional | 01/24/2003SE |
| K023639 | Piccolo Triglycerides Test SystemJGY · Traditional | 01/24/2003SE |
| K022312 | Piccolo Phosphorus Test SystemCEO · Traditional | 09/05/2002SE |
| K010670 | Piccolo Chloride Test SystemCHJ · Traditional | 04/26/2001SE |
| K993211 | Piccolo Sodium Test SystemJGS · Traditional | 10/25/1999SE |
| K992140 | Piccolo Metlyte 7 Reagent DiscJLB · Traditional | 08/26/1999SE |
| K955770 | Gamma Glutamyl Transferase Test SystemJQB · Traditional | 09/09/1996SE |
| K950164 | Piccolo(Tm) Primary Health Panel Reagent RotorCHH · Traditional | 04/13/1995SE |
| K942782 | Piccolo(Tm)JJG · Traditional | 03/13/1995SE |
| K934592 | Epoc 2000 Point-Of-Care Analyzer and Epoc 5-CHEMISTRY Reagent RotorJJG · Traditional | 04/06/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2361-2020 Class II | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55…Incorrect reference ranges of analytes. | 12/11/2019Terminated |
| Z-1066-2011 | Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood…Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of… | 11/19/2010Terminated |
| Z-1155-2010 | Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the…Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results. | 11/16/2009Terminated |
| Z-2287-2008 | Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5…The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | 04/21/2008Terminated |
| Z-2286-2008 | Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot…The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | 04/21/2008Terminated |