# K993356: Coulter Hematology Analyzers with Irf & MRV Analyses

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Apr 20, 2000 after 197 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: 2 generations back to K885093 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter, Sysmex Corp. (1997) Summary page 1.
- K962988: Coulter Gen-S System, Coulter Corp. (1996) Summary page 1.
- K925344: Coulter New Meth Blue Preprep Retic/Maxm W/Autoloa, Coulter Corp. (1993) Summary page 1.

## Indications for use
The COULTER GEN-S System with IRF and MRV Parameters is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER GEN-S System also provides automated Reticulocyte analysis. An automated differential cell counter is a device used to identify and classify one or more of the formed elements of blood.

Source page: https://510kreport.com/device/K993356
Methodology: https://510kreport.com/methodology