Horiba Abx
Medical device manufacturer in Montpellier, FR.
36510(k) clearances
0PMA approvals
0recalls
Device types
- GKZ Counter, Differential Cell 6
- CFR Hexokinase, Glucose 3
- DCK C-Reactive Protein, Antigen, Antiserum, And… 3
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 2
- CJY Azo Dye, Calcium 2
- JFY Enzymatic Method, Creatinine 2
- JIT Calibrator, Secondary 2
- CGX Alkaline Picrate, Colorimetry, Creatinine 2
- CIC Cresolphthalein Complexone, Calcium 1
- CZP Iga, Antigen, Antiserum, Control 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- LCP Assay, Glycosylated Hemoglobin 1
- JIX Calibrator, Multi-Analyte Mixture 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- JFJ Catalytic Methods, Amylase 1
- CIG Diazo Colorimetry, Bilirubin 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- GGP Test, Qualitative And Quantitative Factor… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K232946 | Yumizen H2500GKZ · Traditional | 05/21/2024SE |
| K193649 | Yumizen C1200 Creatinine PAPJFY · Traditional | 05/10/2021SE |
| K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200…CZP · Traditional | 06/26/2020SE |
| K192028 | Yumizen C1200 CRPDCK · Traditional | 06/25/2020SE |
| K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF · Traditional | 03/06/2020SE |
| K191993 | Yumizen C1200 CRPDCK · Traditional | 10/03/2019SE |
| K191245 | Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE · Traditional | 08/30/2019SE |
| K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY · Traditional | 07/26/2019SE |
| K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ · Traditional | 11/01/2017SE |
| K151133 | Pentra XLRGKZ · Traditional | 12/09/2015SE |
| K141161 | Abx Micros Es 60 CT; (Open Tube Model), (Close Tube Model)GKZ · Traditional | 12/20/2014SE |
| K133676 | Abx Pentra Micro Alb Control L/HJJY · Abbreviated | 07/11/2014SE |
| K123171 | Abx Pentra Calcium AS CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra…CJY · Abbreviated | 07/03/2013SE |
| K110530 | Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P…CGX · Abbreviated | 04/30/2012SE |
| K103788 | Pentra C200, Ise Module and Abx Pentra Glucose HK CP ReagentCFR · Traditional | 11/08/2011SE |
| K110137 | Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx…JFY · Abbreviated | 08/10/2011SE |
| K092570 | Abx Pentra Tpu Cal, Model A11A01898JIT · Abbreviated | 10/16/2009SE |
| K073309 | Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis ReagentLCP · Traditional | 10/17/2008SE |
| K081276 | Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/HCFR · Traditional | 09/12/2008SE |
| K071779 | Abx Pentra Urine CalJIX · Abbreviated | 03/05/2008SE |
| K072115 | Abx Pentra Creatinine 120 CP, Total Protein 100 CP, Multical, N and P Controls, and…CGX · Traditional | 11/30/2007SE |
| K070146 | Abx Pentra Glucose HK CP, Urea CP, Uric Acid CPCDQ · Traditional | 10/12/2007SE |
| K062737 | Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerCGS · Traditional | 06/12/2007SE |
| K060434 | Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx…CIX · Traditional | 06/05/2007SE |
| K070249 | Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/HCIC · Traditional | 04/26/2007SE |
| K062180 | Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional | 10/02/2006SE |
| K061138 | Abx Pentra 400 : CRPDCK · Traditional | 09/29/2006SE |
| K060854 | Abx Pentra 400: LipoproteinsJIT · Traditional | 08/24/2006SE |
| K060325 | Abx Pentra Bilirubin, Direct CP, Abx Pentra Bilirubin, Total CP, Abx Pentra Multical…CIG · Traditional | 08/16/2006SE |
| K060318 | Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry AnalyzerCIT · Traditional | 08/08/2006SE |
| K060205 | General Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerCJE · Traditional | 07/21/2006SE |
| K053308 | Abx Micros CRP 200, Option ImGKZ · Special | 12/29/2005SE |
| K052007 | Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module)CFR · Traditional | 12/16/2005SE |
| K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5GGP · Traditional | 09/23/2005SE |
| K050721 | Abx ErytrolJPK · Traditional | 06/01/2005SE |
| K050719 | Abx Pentra DX 120: Option SPS EvolutionGKZ · Traditional | 04/26/2005SE |