# K911626: System 9000, Interpretive Diff Cell Counter

- Pathway: 510(k) (Traditional)
- Applicant: Serono Baker Diagnostics System
- Decided: Sep 13, 1991 after 155 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.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K953598: Series 9100 Plus Automated Differential Hematology Analyzers (1996), 3 descendants of its own
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own
- K960072: Spirit Hematology System Model LE, CP, & AX (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K911626
Methodology: https://510kreport.com/methodology