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HORIBA ABX SAS

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260781 Yumizen H550GKZ2026-09-14 View
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
510(k) K123171 ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONTCJY2013-07-03 View
510(k) K110530 ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROLCGX2012-04-30 View
510(k) K103788 PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTCFR2011-11-08 View
510(k) K110137 ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URINJFY2011-08-10 View
510(k) K092570 ABX PENTRA TPU CAL, MODEL A11A01898JIT2009-10-16 View
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