Company ยท FR
Horiba Abx
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
37510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GKZ | Counter, Differential Cell | 7 |
| CFR | Hexokinase, Glucose | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 |
| CJY | Azo Dye, Calcium | 2 |
| JFY | Enzymatic Method, Creatinine | 2 |
| JIT | Calibrator, Secondary | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2026 | K260781 | Yumizen H550 HORIBA ABX SAS, FR | GKZ |
| May 21, 2024 | K232946 | Yumizen H2500 HORIBA ABX SAS, FR | GKZ |
| May 10, 2021 | K193649 | Yumizen C1200 Creatinine PAP HORIBA ABX SAS, FR | JFY |
| Jun 26, 2020 | K193525 | Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M HORIBA ABX SAS, FR | CZP |
| Jun 25, 2020 | K192028 | Yumizen C1200 CRP HORIBA ABX SAS, FR | DCK |
| Mar 6, 2020 | K191562 | Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor HORIBA ABX SAS, FR | DBF |
| Oct 3, 2019 | K191993 | Yumizen C1200 CRP HORIBA ABX SAS, FR | DCK |
| Aug 30, 2019 | K191245 | Yumizen C1200 ALP, Yumizen C1200 Albumin HORIBA ABX SAS, FR | CJE |
| Jul 26, 2019 | K191396 | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe HORIBA ABX SAS, FR | CJY |
| Nov 1, 2017 | K170353 | ABX MICROS ES 60 OT and ABX MICROS ES 60 CT HORIBA ABX SAS, FR | GKZ |
| Dec 9, 2015 | K151133 | PENTRA XLR HORIBA ABX SAS, FR | GKZ |
| Dec 20, 2014 | K141161 | ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) HORIBA ABX SAS, FR | GKZ |
| Jul 11, 2014 | K133676 | ABX PENTRA MICRO ALB CONTROL L/H HORIBA ABX SAS, FR | JJY |
| Jul 3, 2013 | K123171 | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT HORIBA ABX SAS, FR | CJY |
| Apr 30, 2012 | K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL HORIBA ABX SAS, FR | CGX |
| Nov 8, 2011 | K103788 | PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT HORIBA ABX SAS, FR | CFR |
| Aug 10, 2011 | K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN HORIBA ABX SAS, FR | JFY |
| Oct 16, 2009 | K092570 | ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS, FR | JIT |
| Oct 17, 2008 | K073309 | ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT Horiba Abx, FR | LCP |
| Sep 12, 2008 | K081276 | ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H Horiba Abx, FR | CFR |
| Mar 5, 2008 | K071779 | ABX PENTRA URINE CAL Horiba Abx, FR | JIX |
| Nov 30, 2007 | K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H Horiba Abx, FR | CGX |
| Oct 12, 2007 | K070146 | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP Horiba Abx, FR | CDQ |
| Jun 12, 2007 | K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, FR | CGS |
| Jun 5, 2007 | K060434 | ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL Horiba Abx, FR | CIX |
| Apr 26, 2007 | K070249 | ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H Horiba Abx, FR | CIC |
| Oct 2, 2006 | K062180 | ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP Horiba Abx, FR | JFJ |
| Sep 29, 2006 | K061138 | ABX PENTRA 400 : CRP Horiba Abx, FR | DCK |
| Aug 24, 2006 | K060854 | ABX PENTRA 400: LIPOPROTEINS Horiba Abx, FR | JIT |
| Aug 16, 2006 | K060325 | ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P Horiba Abx, FR | CIG |
| Aug 8, 2006 | K060318 | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, FR | CIT |
| Jul 21, 2006 | K060205 | GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER Horiba Abx, FR | CJE |
| Dec 29, 2005 | K053308 | ABX MICROS CRP 200, OPTION IM Horiba Abx, FR | GKZ |
| Dec 16, 2005 | K052007 | ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) Horiba Abx, FR | CFR |
| Sep 23, 2005 | K050448 | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 Horiba Abx, FR | GGP |
| Jun 1, 2005 | K050721 | ABX ERYTROL Horiba Abx, FR | JPK |
| Apr 26, 2005 | K050719 | ABX PENTRA DX 120: OPTION SPS EVOLUTION Horiba Abx, FR | GKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||