Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2939693

FEI Number

2939693

Entity Name

ABAXIS, INC.

City/State/Country

UNION CITY, CA, US

Establishment Address

3240 WHIPPLE RD., UNION CITY, CA 94587, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ZOETIS, INC. (Owner Number: 9000378)

Owner / Operator Contact Address

3240 WHIPPLE RD., --, Union City, CA 94587, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K992140

PMA Number

N/A

All Registered Proprietary Names

PICCOLO CHLORIDE TEST SYSTEM PICCOLO PHOSPHORUS TEST SYSTEM Piccolo CRP Test System PICCOLO MAGNESIUM TEST SYSTEM PICCOLO TRIGLYCERIDE TEST SYSTEM PICCOLO HIGH DENSITY LIPOPROTEIN (H Aspartate Aminotransferase (AST) Uric Acid Piccolo Xpress PICCOLO GGT TEST SYSTEM PICCOLO PRIMARY HEALTH PANEL Piccolo Uric Acid Test System PICCOLO LACTATE DEHY Piccolo Lactate Test System Total Carbon Dioxide Creatine Kinase Enzymatic Potassium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	Clinical Chemistry	Class 2	862.1170	2009-03-27
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2006-01-10
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2010-03-26
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2006-01-10
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	2003-06-30
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2003-06-30
JJG	Analyzer, Chemistry, Centrifugal, For Clinical Use	Clinical Chemistry	Class 1	862.2140	2006-01-20
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2001-05-21
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2007-05-30
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2007-05-30
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2007-05-30
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2007-05-30
CDN	Urease, Photometric, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2007-05-30
CKF	Phenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2007-05-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2007-05-30
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2007-05-30
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2007-05-30
CIJ	Saccharogenic, Amylase	Clinical Chemistry	Class 2	862.1070	2007-05-30
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2007-05-30
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2007-05-30
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2015-04-30
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2006-01-10
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	2013-05-02
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-03-29
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-03-29
JLB	Atp And Creatine Kinase (Enzymatic), Creatine	Clinical Chemistry	Class 1	862.1210	2012-03-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ZOETIS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083412	Mitsubishi Kagaku Iatron	PATHFAST HSCRP	2009-03-09
K881300	Medical Analysis Systems, Inc.	MAGNESIUM LIQUID STABLE REAGENT SET	1988-05-17
K162399	Siemens Healthcare Diagnostics, Inc.	Atellica CH Magnesium (Mg)	2017-01-19
K861663	Data Medical Associates, Inc.	TOTAL PROTEIN PROCEDURE	1986-06-13
K832169	Sandare Chemical Co., Inc.	TOTAL PROTEIN PROCEDURE	1983-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2014	Abbott Laboratories, Inc	1	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Z-0012-2009	Roche Diagnostics Corp.	2	Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2939693. Last updated year: 2026. Please use registration number 2939693 when referencing this establishment in official correspondence.