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HORIBA ABX SAS

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Yumizen H2500 (K232946)HORIBA ABX SAS2024-05-21
Yumizen C1200 Creatinine PAP (K193649)HORIBA ABX SAS2021-05-10
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M (K193525)HORIBA ABX SAS2020-06-26
Yumizen C1200 CRP (K192028)HORIBA ABX SAS2020-06-25
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (K191562)HORIBA ABX SAS2020-03-06
Yumizen C1200 CRP (K191993)HORIBA ABX SAS2019-10-03
Yumizen C1200 ALP, Yumizen C1200 Albumin (K191245)HORIBA ABX SAS2019-08-30
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396)HORIBA ABX SAS2019-07-26
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT (K170353)HORIBA ABX SAS2017-11-01
PENTRA XLR (K151133)HORIBA ABX SAS2015-12-09
ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) (K141161)HORIBA ABX SAS2014-12-20
ABX PENTRA MICRO ALB CONTROL L/H (K133676)HORIBA ABX SAS2014-07-11
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT (K123171)HORIBA ABX SAS2013-07-03
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL (K110530)HORIBA ABX SAS2012-04-30
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT (K103788)HORIBA ABX SAS2011-11-08
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN (K110137)HORIBA ABX SAS2011-08-10
ABX PENTRA TPU CAL, MODEL A11A01898 (K092570)HORIBA ABX SAS2009-10-16

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Every clearance here is in the API, with alerts when new ones post.