Chrysalis Intelligence · Sponsors · HORIBA ABX SAS

HORIBA ABX SAS

Montpellier Cedex 4, FR · 5 510(k) clearances

Total clearances
5
2020-03-06 → 2024-05-21
Last 12 months
0
Product codes
5
Most recent
2024-05-21
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GKZ 1 2024-05-21
JFY Enzymatic Method, Creatinine Class II Clinical Chemistry 1 2021-05-10
CZP Iga, Antigen, Antiserum, Control Class II Immunology 1 2020-06-26
DCK C-Reactive Protein, Antigen, Antiserum, And Control Class II Immunology 1 2020-06-25
DBF Ferritin, Antigen, Antiserum, Control Class II Immunology 1 2020-03-06
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2024-05-21 K232946 Yumizen H2500 GKZ
2021-05-10 K193649 Yumizen C1200 Creatinine PAP JFY Class II Clinical Chemistry
2020-06-26 K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M CZP Class II Immunology
2020-06-25 K192028 Yumizen C1200 CRP DCK Class II Immunology
2020-03-06 K191562 Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor DBF Class II Immunology