FDA 510(k) Applications Submitted by HORIBA ABX SAS

FDA 510(k) Number	Submission Date	Device Name	Applicant
K170353	02/03/2017	ABX MICROS ES 60 OT and ABX MICROS ES 60 CT	HORIBA ABX SAS
K151133	04/28/2015	PENTRA XLR	HORIBA ABX SAS
K191245	05/09/2019	Yumizen C1200 ALP, Yumizen C1200 Albumin	HORIBA ABX SAS
K191396	05/24/2019	Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe	Horiba ABX SAS
K191562	06/13/2019	Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor	HORIBA ABX SAS
K191993	07/25/2019	Yumizen C1200 CRP	Horiba ABX SAS
K192028	07/26/2019	Yumizen C1200 CRP	Horiba ABX SAS
K092570	08/21/2009	ABX PENTRA TPU CAL, MODEL A11A01898	HORIBA ABX SAS
K133676	11/29/2013	ABX PENTRA MICRO ALB CONTROL L/H	HORIBA ABX SAS
K193525	12/19/2019	Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M	Horiba ABX SAS
K103788	12/27/2010	PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT	HORIBA ABX SAS
K193649	12/30/2019	Yumizen C1200 Creatinine PAP	Horiba ABX SAS
K141161	05/05/2014	ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)	HORIBA ABX SAS