# K935720: Ortho Count Calibration Kit for Ortho Cytoronabsolute Laser Flow Cytometry System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Diagnostic Systems, Inc.
- Decided: May 9, 1996 after 891 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 K813375 (1982). 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)
- K813375: Hematology Calibrator S-Cal, Coulter Electronics, Inc. (1982) Summary page 2.

## Indications for use
ortho-Count Calibration Kit for ORTHO CYTORONABSOLUTE Laser Flow Cytometry System is intended to be used to calibrate and verify calibration of the absolute lymphocyte counting function of the ORTHO CYTORONABSOLUTE.

Source page: https://510kreport.com/device/K935720
Methodology: https://510kreport.com/methodology