# K991070: Coulter Z2 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: May 11, 1999 after 41 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- 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 K885093 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952308: Coulter Z 1, Coulter Corp. (1995) Summary page 2.
- K885093: Coulter STKS, Coulter Electronics, Inc. (1988) Summary page 2.

## Indications for use
The COULTER® Z2 instrument may be used for in vitro diagnostic use to determine the human erythrocyte concentration (Red Cell Count or RBC), leukocyte concentration (White Cell Count or WBC) and thrombocyte concentration (Platelet Count or Plt). In addition, the COULTER Z2 also provides the mean erythrocyte volume (Mean Cell Volume or MCV) and the mean thrombocyte volume (Mean Platelet Volume or MPV).

Source page: https://510kreport.com/device/K991070
Methodology: https://510kreport.com/methodology