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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
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