Data / Medical devices / United States / Abaxis, Inc.
Abaxis, Inc.: FDA-registered device maker in Union City, CA, United States, 11 510(k) clearances
Abaxis, Inc. is registered with the FDA (registration 2939693) in Union City, CA, United States. It lists 28 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 11, 2013. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2939693
- Address
- 3240 Whipple RD., Union City, CA, United States, 94587
- Owner or operator
- ZOETIS, INC. (9000378)
- Roles
- Manufacturer
- First device listed
- May 21, 2001
- Registered through
- 2026
- Brand names listed
- Aspartate Aminotransferase (AST), Creatine Kinase, Enzymatic Potassium, PICCOLO 9-CHEM REAGENT ROTOR, PICCOLO CHLORIDE TEST SYSTEM, PICCOLO GGT TEST SYSTEM, PICCOLO HIGH DENSITY LIPOPROTEIN (H, PICCOLO LACTATE DEHY and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 11, 2013 | K130113 | PICCOLO LACTATE TEST SYSTEM | KHP | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| January 15, 2010 | K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | DCN | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| July 8, 2005 | K051108 | PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM | CFJ | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| January 30, 2004 | K040115 | PICCOLO MAGNESIUM TEST SYSTEM | JGJ | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| September 5, 2002 | K022312 | PICCOLO PHOSPHORUS TEST SYSTEM | CEO | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| April 26, 2001 | K010670 | PICCOLO CHLORIDE TEST SYSTEM | CHJ | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| October 25, 1999 | K993211 | PICCOLO SODIUM TEST SYSTEM | JGS | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| August 26, 1999 | K992140 | PICCOLO METLYTE 7 REAGENT DISC | JLB | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| April 13, 1995 | K950164 | PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTOR | CHH | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| March 13, 1995 | K942782 | PICCOLO(TM) | JJG | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
| April 6, 1994 | K934592 | EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR | JJG | Substantially Equivalent | Abaxis, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 11, 2019 | 85533 | Class II | Terminated | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55 (NGA)/3.1.35(Jen II) | Incorrect reference ranges of analytes. | accessdata.fda.gov |
| November 19, 2010 | 57321 | Not yet classified | Terminated | Abaxis brand Piccolo Comprehensive Metabolic Panel; Used with the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer; Catalog/Part Number:; Product is manufactured and distributed by Abaxis, Incorporat | Abaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo Blood Chemistry Analyzer or Piccolo xpress Chemistry Analyzer. | accessdata.fda.gov |
| November 16, 2009 | 53848 | Not yet classified | Terminated | Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No., manufactured by Abaxis Inc., Union City, CA Medical dev | Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results. | accessdata.fda.gov |
| April 21, 2008 | 48709 | Not yet classified | Terminated | Piccolo Chemistry Analyzer software version 6.121 with Comprehensive Metabolic Lot #8111AA5, Model Number in polyfoil pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-contained reagent disk, intended for | The product will recover tCO2 at approximately 5-7 units high relative to some controls and patient samples | accessdata.fda.gov |
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Updated March 11, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.