# K904464: CBC-Laser (R) Hematology Control/Multiple-Modified

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Oct 23, 1990 after 22 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K970331: CBC-4K Hematology Control (1997), 1 descendant of its own
- K072268: HC WBC Hematology Control, Model: WBC00S (2007), 0 descendants of its own
- K051339: R&D CBC-4K Plus Retics Hematology Control (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K904464
Methodology: https://510kreport.com/methodology