# K032214: Medonic CA620/530 Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boule Medical AB
- Decided: Jan 29, 2004 after 192 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens. 21 CFR 864.5220 Automated differential cell counter Automated differential cell counters are used to identify and classify one or more populations of formed elements in whole blood specimens

Source page: https://510kreport.com/device/K032214
Methodology: https://510kreport.com/methodology