# K913879: CBC-8K (TM) Hematology Control/Multiple

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Nov 27, 1991 after 90 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; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042094: R&D CBC-XE Hematology Control (2004), 2 descendants of its own
- K160606: BC-5D Hematology Control (2016), 0 descendants of its own
- K100050: R & D Systems Xeret Hematology Control (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K913879
Methodology: https://510kreport.com/methodology