# K012904: Advia 120 Hematology System, Cyanide-Free High Determination

- Pathway: 510(k) (Special)
- Applicant: Bayer Diagnostics Corp.
- Decided: Sep 21, 2001 after 23 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: 1 generation back to K971998 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971998: Advia 120 Hematology System, in Vitro Diagnostic System, Bayer Corp. (1997) Summary page 1.

## Indications for use
The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.

Source page: https://510kreport.com/device/K012904
Methodology: https://510kreport.com/methodology