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HORIBA ABX SAS

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories7
Latest Approval2024-05-21
TypeNumberDevice NameCodeDate
510(k) K232946 Yumizen H2500 GKZ 2024-05-21 View
510(k) K193649 Yumizen C1200 Creatinine PAP JFY 2021-05-10 View
510(k) K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M CZP 2020-06-26 View
510(k) K192028 Yumizen C1200 CRP DCK 2020-06-25 View
510(k) K191562 Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor DBF 2020-03-06 View
510(k) K191993 Yumizen C1200 CRP DCK 2019-10-03 View
510(k) K191245 Yumizen C1200 ALP, Yumizen C1200 Albumin CJE 2019-08-30 View
510(k) K191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe CJY 2019-07-26 View
510(k) K170353 ABX MICROS ES 60 OT and ABX MICROS ES 60 CT GKZ 2017-11-01 View