510(k) Report

FDA applicant

Abaxis, Inc.

Union City, CA20 decisions1994–20215 recalls

FDA records 20 decisions for Abaxis, Inc. (Union City, CA) from 1994 to 2021: 20 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and JJG (Analyzer, Chemistry, Centrifugal, For Clinical…). Its devices cite 17 predicates, 3 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Abaxis, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2009: 12010: 12012: 22013: 22021: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2008: 22009: 12010: 12019: 1
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Abaxis, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CHHEnzymatic Esterase--Oxidase, Cholesterol3decisions
  • JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use2decisions
  • JGYColorimetric Method, Triglycerides2decisions
  • JGJPhotometric Method, Magnesium2decisions
  • JQBKinetic Method, Gamma-Glutamyl Transpeptidase1decision
  • DCNSystem, Test, C-Reactive Protein1decision

Also: LBS (1), MZV (1), JLB (1), CHJ (1), CEO (1), JHM (1).

Whose devices does it build on?

Its devices cite 17 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K942782Piccolo (TM)Abaxis, Inc. · 19957cite it
  • K950164Piccolo (TM) Primary Health Panel Reagent RotorAbaxis, Inc. · 19952cite it
  • K023639Piccolo Triglycerides Test SystemAbaxis, Inc. · 20032cite it
  • K023642Piccolo Total Cholesterol Test SystemAbaxis, Inc. · 20031cites it
  • K023640Piccolo HDL Test SystemAbaxis, Inc. · 20031cites it
  • K992140Piccolo Metlyte 7 Reagent DiscAbaxis, Inc. · 19991cites it

What has FDA decided for it lately?

  • K200865Piccolo Potassium Test SystemAbaxis, Inc. · 2021
  • K130113Piccolo Lactate Test SystemAbaxis, Inc. · 2013
  • K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc. · 2013
  • K120664Piccolo Trglycerides-Capillary Test SystemAbaxis, Inc. · 2012
  • K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc. · 2012
  • K091052Piccolo C-Reactive Protein (CRP) Test SystemAbaxis, Inc. · 2010
  • K091910Piccolo Magnesium Test SystemAbaxis, Inc. · 2009
  • K051108Piccolo Lactate Dephydrogenase Test SystemAbaxis, Inc. · 2005

All 20 as Abaxis, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K934592Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55…Dec 11, 2019Class II
  • K950164Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood…Nov 19, 2010
  • K942782Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the…Nov 16, 2009
  • K992140Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5…Apr 21, 2008
  • K992140Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot…Apr 21, 2008