# K970331: CBC-4K Hematology Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Apr 16, 1997 after 78 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
Longest line of descent: 1 generation back to K904464 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904464: CBC-Laser (R) Hematology Control/Multiple-Modified, R&D Systems, Inc. (1990) Summary page 1.

## Most influential descendants
- K051339: R&D CBC-4K Plus Retics Hematology Control (2005), 0 descendants of its own

## Indications for use
CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn® hematology instruments.

Source page: https://510kreport.com/device/K970331
Methodology: https://510kreport.com/methodology