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Data / Medical devices / France / Horiba Abx SAS

Horiba Abx SAS: FDA-registered device maker in MONTPELLIER Herault, France, 39 510(k) clearances

Horiba Abx SAS is registered with the FDA (registration 3000148879) in MONTPELLIER Herault, France. It lists 63 device types. The FDA files 39 510(k) clearances under its listings, the newest dated September 14, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Horiba Abx SAS
FDA registration number
3000148879
Address
Parc Euromedecine Rue Du Caducee, BP 7290, MONTPELLIER Herault, France, 34184
Owner or operator
HORIBA ABX SAS (9036328)
Roles
Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
July 24, 2000
Registered through
2026
Brand names listed
ABX ALPHALYSE 360mL, ABX Alphalyse 0.4L, ABX BASOLYSE, ABX BASOLYSE II, ABX CLEANER (1L), ABX CRP CAL, ABX CRP REA, ABX CRP STD and more

Devices it lists

DeviceProduct codeClassRoleSource
Acid, Lactic, Enzymatic MethodKHP1Specification developeraccessdata.fda.gov
Acid, Uric, Uricase (Colorimetric)KNK1Specification developeraccessdata.fda.gov
Albumin, Antigen, Antiserum, ControlDCF2Specification developeraccessdata.fda.gov
Alkaline Picrate, Colorimetry, CreatinineCGX2Manufacturer, Specification developeraccessdata.fda.gov
Analyzer, Chemistry (Photometric, Discrete), For Clinical UseJJE1Manufacturer, Specification developeraccessdata.fda.gov
Azo Dye, CalciumCJY2Specification developeraccessdata.fda.gov
Biuret (Colorimetric), Total ProteinCEK2Specification developeraccessdata.fda.gov
Bromcresol Green Dye-Binding, AlbuminCIX2Specification developeraccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Manufacturer, Specification developeraccessdata.fda.gov
Calculator/Data Processing Module, For Clinical UseJQP1Manufacturer, Specification developeraccessdata.fda.gov
Calibrator For Cell IndicesKRX2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit MeasurementKRZ2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator For Platelet CountingKRY2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator For Red-Cell And White-Cell CountingKSA2Repackager or relabeler, Specification developeraccessdata.fda.gov
Calibrator, Multi-Analyte MixtureJIX2Manufacturer, Specification developeraccessdata.fda.gov
Calibrator, PrimaryJIS2Manufacturer, Specification developeraccessdata.fda.gov
Calibrator, SecondaryJIT2Manufacturer, Specification developeraccessdata.fda.gov
Catalytic Methods, AmylaseJFJ2Manufacturer, Specification developeraccessdata.fda.gov
Counter, Cell, Automated (Particle Counter)GKL2Contract manufactureraccessdata.fda.gov
Counter, Differential CellGKZ2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Cresolphthalein Complexone, CalciumCIC2Manufacturer, Specification developeraccessdata.fda.gov
Diazo Colorimetry, BilirubinCIG2Specification developeraccessdata.fda.gov
Diluent, Blood CellGIF1Contract manufacturer, Manufactureraccessdata.fda.gov
Electrode, Ion Specific, PotassiumCEM2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion Specific, SodiumJGS2Manufacturer, Specification developeraccessdata.fda.gov
Electrode, Ion-Specific, ChlorideCGZ2Manufacturer, Specification developeraccessdata.fda.gov
Enzymatic Esterase--Oxidase, CholesterolCHH1Manufacturer, Specification developeraccessdata.fda.gov
Enzymatic Method, CreatinineJFY2Specification developeraccessdata.fda.gov
Enzymatic, Carbon-DioxideKHS2Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Specification developeraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Specification developeraccessdata.fda.gov
General Purpose ReagentPPM1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Hexokinase, GlucoseCFR2Manufacturer, Specification developeraccessdata.fda.gov
Iga, Antigen, Antiserum, ControlCZP2Specification developeraccessdata.fda.gov
Igg, Antigen, Antiserum, ControlDEW2Specification developeraccessdata.fda.gov
Igm, Antigen, Antiserum, ControlDFT2Specification developeraccessdata.fda.gov
Kinetic Method, Gamma-Glutamyl TranspeptidaseJQB1Specification developeraccessdata.fda.gov
Ldl & Vldl Precipitation, HdlLBR1Manufacturer, Specification developeraccessdata.fda.gov
Lipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesCDT1Manufacturer, Specification developeraccessdata.fda.gov
Lipase-Esterase, Enzymatic, Photometric, LipaseCHI1Specification developeraccessdata.fda.gov
Method, Nephelometric, Immunoglobulins (G, A, M)CFN2Specification developeraccessdata.fda.gov
Mixture, Hematology Quality ControlJPK2Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)JJY1Manufacturer, Specification developeraccessdata.fda.gov
Myoglobin, Antigen, Antiserum, ControlDDR2Specification developeraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Cpk Or IsoenzymesCGS2Specification developeraccessdata.fda.gov
Nad Reduction/Nadh Oxidation, Lactate DehydrogenaseCFJ2Specification developeraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Alt/SgptCKA1Specification developeraccessdata.fda.gov
Nadh Oxidation/Nad Reduction, Ast/SgotCIT2Specification developeraccessdata.fda.gov
Nitrophenylphosphate, Alkaline Phosphatase Or IsoenzymesCJE2Specification developeraccessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic PhosphorusCEO1Manufacturer, Specification developeraccessdata.fda.gov
Photometric Method, Iron (Non-Heme)JIY1Specification developeraccessdata.fda.gov
Photometric Method, MagnesiumJGJ1Specification developeraccessdata.fda.gov
Prealbumin, Antigen, Antiserum, ControlJZJ1Specification developeraccessdata.fda.gov
Products, Red-Cell Lysing ProductsGGK1Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)JJX1Manufacturer, Specification developeraccessdata.fda.gov
Slide Stainer, AutomatedKPA1Contract manufacturer, Manufactureraccessdata.fda.gov
Stains, Chemical SolutionLED1Contract manufacturer, Manufactureraccessdata.fda.gov
Stains, HematologyKQC1Exporter to the USaccessdata.fda.gov
System, Test, Low Density, LipoproteinMRR1Manufacturer, Specification developeraccessdata.fda.gov
System, Test, Rheumatoid FactorDHR2Specification developeraccessdata.fda.gov
Transferrin, Antigen, Antiserum, ControlDDG2Specification developeraccessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)JIQ1Specification developeraccessdata.fda.gov
Urease And Glutamic Dehydrogenase, Urea NitrogenCDQ2Specification developeraccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 14, 2026K260781Yumizen H550GKZSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
May 21, 2024K232946Yumizen H2500GKZSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
May 10, 2021K193649Yumizen C1200 Creatinine PAPJFYSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
June 26, 2020K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MCZPSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
March 6, 2020K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBFSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
October 3, 2019K191993Yumizen C1200 CRPDCKSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
August 30, 2019K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminCJESubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
July 26, 2019K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJYSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
February 12, 2019K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeJJESubstantially EquivalentHoriba, Ltd.accessdata.fda.gov
December 9, 2015K151133PENTRA XLRGKZSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
December 20, 2014K141161ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)GKZSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
July 3, 2013K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTCJYSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
April 30, 2012K110530ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLCGXSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
November 8, 2011K103788PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTCFRSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
August 10, 2011K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINJFYSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
October 16, 2009K092570ABX PENTRA TPU CAL, MODEL A11A01898JITSubstantially EquivalentHORIBA ABX SASaccessdata.fda.gov
September 12, 2008K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HCFRSubstantially EquivalentHoriba Abxaccessdata.fda.gov
November 30, 2007K072115ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HCGXSubstantially EquivalentHoriba Abxaccessdata.fda.gov
October 12, 2007K070146ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CPCDQSubstantially EquivalentHoriba Abxaccessdata.fda.gov
June 12, 2007K062737CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCGSSubstantially EquivalentHoriba Abxaccessdata.fda.gov
June 5, 2007K060434ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICALCIXSubstantially EquivalentHoriba Abxaccessdata.fda.gov
April 26, 2007K070249ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/HCICSubstantially EquivalentHoriba Abxaccessdata.fda.gov
October 2, 2006K062180ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CPJFJSubstantially EquivalentHoriba Abxaccessdata.fda.gov
September 29, 2006K061138ABX PENTRA 400 : CRPDCKSubstantially EquivalentHoriba Abxaccessdata.fda.gov
August 24, 2006K060854ABX PENTRA 400: LIPOPROTEINSJITSubstantially EquivalentHoriba Abxaccessdata.fda.gov
August 16, 2006K060325ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA PCIGSubstantially EquivalentHoriba Abxaccessdata.fda.gov
August 8, 2006K060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCITSubstantially EquivalentHoriba Abxaccessdata.fda.gov
July 21, 2006K060205GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERCJESubstantially EquivalentHoriba Abxaccessdata.fda.gov
July 10, 2006K061511R&D CBC-3D + CRP HEMATOLOGY CONTROLJPKSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
December 29, 2005K053308ABX MICROS CRP 200, OPTION IMGKZSubstantially EquivalentHoriba Abxaccessdata.fda.gov
December 16, 2005K052007ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE)CFRSubstantially EquivalentHoriba Abxaccessdata.fda.gov
April 8, 2003K030799MICROS 60GKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
January 31, 2003K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+GKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
January 3, 2003K024002PENTRA 80GKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
December 1, 2000K003534PENTRA 5DJPKSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
October 26, 2000K002646ABX MICROS CRPGKZSubstantially EquivalentAbx Diagnosticsaccessdata.fda.gov
February 29, 1996K955925CBC-CAL PLUS HEMATOLOGY CALIBRATORKRXSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
December 12, 1994K943336RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLEJPKSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov
November 1, 1984K843962CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLEJPKSubstantially EquivalentR&D Systems, Inc.accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. 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.