Company ยท US
Abaxis, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2021. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 3 |
| JLB | Atp And Creatine Kinase (Enzymatic), Creatine | 3 |
| JGJ | Photometric Method, Magnesium | 2 |
| JGY | Colorimetric Method, Triglycerides | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JHM | Colorimetric Method, Lipoproteins | 1 |
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| MZV | Test, System, Potassium, Enzymatic Method | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2021 | K200865 | Piccolo Potassium Test System Abaxis, Inc. | MZV |
| Mar 11, 2013 | K130113 | PICCOLO LACTATE TEST SYSTEM Abaxis, Inc. | KHP |
| Feb 15, 2013 | K130200 | PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM Abaxis, Inc. | CHH |
| Apr 24, 2012 | K120664 | PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM Abaxis, Inc. | JGY |
| Apr 24, 2012 | K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM Abaxis, Inc. | JHM |
| Jan 15, 2010 | K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM Abaxis, Inc. | DCN |
| Oct 1, 2009 | K091910 | PICCOLO MAGNESIUM TEST SYSTEM Abaxis, Inc. | JGJ |
| Jul 8, 2005 | K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM Abaxis, Inc. | CFJ |
| Jan 30, 2004 | K040115 | PICCOLO MAGNESIUM TEST SYSTEM Abaxis, Inc. | JGJ |
| Jan 24, 2003 | K023642 | PICCOLO TOTAL CHOLESTEROL TEST SYSTEM Abaxis, Inc. | CHH |
| Jan 24, 2003 | K023640 | PICCOLO HDL TEST SYSTEM Abaxis, Inc. | LBS |
| Jan 24, 2003 | K023639 | PICCOLO TRIGLYCERIDES TEST SYSTEM Abaxis, Inc. | JGY |
| Sep 5, 2002 | K022312 | PICCOLO PHOSPHORUS TEST SYSTEM Abaxis, Inc. | CEO |
| Apr 26, 2001 | K010670 | PICCOLO CHLORIDE TEST SYSTEM Abaxis, Inc. | CHJ |
| Oct 25, 1999 | K993211 | PICCOLO SODIUM TEST SYSTEM Abaxis, Inc. | JGS |
| Aug 26, 1999 | K992140 | PICCOLO METLYTE 7 REAGENT DISC Abaxis, Inc. | JLB |
| Sep 9, 1996 | K955770 | GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM Abaxis, Inc. | JQB |
| Apr 13, 1995 | K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR Abaxis, Inc. | CHH |
| Mar 13, 1995 | K942782 | PICCOLO(TM) Abaxis, Inc. | JJG |
| Apr 6, 1994 | K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR Abaxis, Inc. | JJG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2019 | Abaxis Inc Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) Terminated |
JJG | K934592 |
| Feb 9, 2011 | Abaxis, Incorporated Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number: 400-0028;
Product is manufactured and dis Terminated |
CKA | K950164 |
| Mar 16, 2010 | Abaxis Inc Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028, manufactured by Abaxis Inc Terminated |
JFY | K942782 |
| Sep 17, 2008 | Abaxis Inc Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel Lot #8041AC5, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a single-use, self-contained reagent dis Terminated |
JLB | K992140 |
| Sep 17, 2008 | Abaxis Inc Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5 , Model Number 400-1028 in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-conta Terminated |
JLB | K992140 |