Horiba Abx SAS
MONTPELLIER Herault, FR
HORIBA ABX SAS appears in FDA device records in MONTPELLIER Herault, FR. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Horiba Abx SAS between 2009 and 2024. The busiest year on record is 2019, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232946 | Yumizen H2500 | GKZ | Substantially Equivalent | |
| K193649 | Yumizen C1200 Creatinine PAP | JFY | Substantially Equivalent | |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M | CZP | Substantially Equivalent | |
| K192028 | Yumizen C1200 CRP | DCK | Substantially Equivalent | |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor | DBF | Substantially Equivalent | |
| K191993 | Yumizen C1200 CRP | DCK | Substantially Equivalent | |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin | CJE | Substantially Equivalent | |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | CJY | Substantially Equivalent | |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT | GKZ | Substantially Equivalent | |
| K151133 | PENTRA XLR | GKZ | Substantially Equivalent | |
| K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) | GKZ | Substantially Equivalent | |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | JJY | Substantially Equivalent | |
| K123171 | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT | CJY | Substantially Equivalent | |
| K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | CGX | Substantially Equivalent | |
| K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT | CFR | Substantially Equivalent | |
| K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN | JFY | Substantially Equivalent | |
| K092570 | ABX PENTRA TPU CAL, MODEL A11A01898 | JIT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3000148879 | 3000148879 | HORIBA ABX SAS | PARC EUROMEDECINE, MONTPELLIER Herault 34184 FR | 2026 | and 53 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- KNKAcid, Uric, Uricase (Colorimetric)
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JQPCalculator/Data Processing Module, For Clinical Use
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- GIFDiluent, Blood Cell
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- DBFFerritin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- JPKMixture, Hematology Quality Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JZJPrealbumin, Antigen, Antiserum, Control
- GGKProducts, Red-Cell Lysing Products
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KPASlide Stainer, Automated
- LEDStains, Chemical Solution
- KQCStains, Hematology
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain