# K960072: Spirit Hematology System Model LE, CP, & AX

- Pathway: 510(k) (Traditional)
- Applicant: Biochem Immunosystems (U.S.), Inc.
- Decided: Mar 6, 1997 after 426 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 K911626 (1991). 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)
- K911626: System 9000, Interpretive Diff Cell Counter, Serono Baker Diagnostics System (1991) Summary page 1.

## Indications for use
The Spirit™ is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument.

Source page: https://510kreport.com/device/K960072
Methodology: https://510kreport.com/methodology