ABX MICROS ES 60 OT and ABX MICROS ES 60 CT— 510(k) K170353

Clearance details

Applicant

HORIBA ABX SAS

Product code

Code GKZ

Device class

Class 2

Regulation

21 CFR 864.5220

Advisory panel

Hematology

Date received

2017-02-03

Decision date

2017-11-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montpellier, FR

• K253212 — XR-Series (XR-10, XR-20) Automated Hematology Analyzers2026-05-27
• K243348 — Athelas Home2026-02-06
• K251249 — Tru Hematology Test2026-01-16
• K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer2025-06-25
• K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer2025-06-25

• K232946 — Yumizen H25002024-05-21
• K193649 — Yumizen C1200 Creatinine PAP2021-05-10
• K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M2020-06-26
• K192028 — Yumizen C1200 CRP2020-06-25
• K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor2020-03-06

Malfunction

1,205

Total

1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →