# K032524: Advia 60 Hematology Analyzer

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Sep 8, 2003 after 24 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 K872166 (1987). 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)
- K982802: Bayer Advia 60 Hematology System (in Vitro Diagnostic System), Bayer Corp. (1998) Summary page 1.
- K961439: Abbott Cell-Dyn 4000 System, Abbott Diagnostics (1996) Summary page 1.

## Indications for use
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.

Source page: https://510kreport.com/device/K032524
Methodology: https://510kreport.com/methodology