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HORIBA ABX SAS

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

Total Devices9
Categories7
Latest FDA decision2024-05-21
TypeNumberDevice NameCodeDateActions
510(k) K232946 Yumizen H2500GKZ2024-05-21 View
510(k) K193649 Yumizen C1200 Creatinine PAPJFY2021-05-10 View
510(k) K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MCZP2020-06-26 View
510(k) K192028 Yumizen C1200 CRPDCK2020-06-25 View
510(k) K191562 Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorDBF2020-03-06 View
510(k) K191993 Yumizen C1200 CRPDCK2019-10-03 View
510(k) K191245 Yumizen C1200 ALP, Yumizen C1200 AlbuminCJE2019-08-30 View
510(k) K191396 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeCJY2019-07-26 View
510(k) K170353 ABX MICROS ES 60 OT and ABX MICROS ES 60 CTGKZ2017-11-01 View
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