FDA 510(k) Applications Submitted by Caroline Ferrer
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110137 |
01/18/2011 |
ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN |
HORIBA ABX S.A.S. |
| K170353 |
02/03/2017 |
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT |
HORIBA ABX SAS |
| K110530 |
02/24/2011 |
ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL |
HORIBA ABX S.A.S. |
| 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 |
| K232946 |
09/20/2023 |
Yumizen H2500 |
Horiba ABX Sas |
| K123171 |
10/09/2012 |
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT |
HORIBA ABX S.A.S. |
| 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 |
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