Horiba Abx

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
36
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K232946Yumizen H2500May 21, 2024
K193649Yumizen C1200 Creatinine PAPMay 10, 2021
K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin MJune 26, 2020
K192028Yumizen C1200 CRPJune 25, 2020
K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid FactorMarch 6, 2020
K191993Yumizen C1200 CRPOctober 3, 2019
K191245Yumizen C1200 ALP, Yumizen C1200 AlbuminAugust 30, 2019
K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine JaffeJuly 26, 2019
K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CTNovember 1, 2017
K151133PENTRA XLRDecember 9, 2015
K141161ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)December 20, 2014
K133676ABX PENTRA MICRO ALB CONTROL L/HJuly 11, 2014
K123171ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AJuly 3, 2013
K110530ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX April 30, 2012
K103788PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENTNovember 8, 2011
K110137ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL,August 10, 2011
K092570ABX PENTRA TPU CAL, MODEL A11A01898October 16, 2009
K073309ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENTOctober 17, 2008
K081276ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/HSeptember 12, 2008
K071779ABX PENTRA URINE CALMarch 5, 2008