# K141161: Abx Micros ES 60 CT; (Open Tube Model), (Close Tube Model)

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx Sas
- Decided: Dec 20, 2014 after 229 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962633 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030799: Micros 60, Abx Diagnostics (2003) Summary page 9.

## Indications for use
The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

Source page: https://510kreport.com/device/K141161
Methodology: https://510kreport.com/methodology