# K934497: CBC-STK (TM) Hematology Control/Multiple

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Dec 6, 1993 after 83 days
- Product code: JCN (Control, Cell Counter, Normal And Abnormal)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K983032: CBC-5D Hematology Control (1999), 3 descendants of its own
- K072096: CBC-5D Plus Retics Hematology Control, Models: 5DR03, 5DR04 (2007), 1 descendant of its own
- K130962: R&D 5D Retic Hematology Control (2013), 0 descendants of its own
- K061320: R&D LH-NRBC Hematology Control (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K934497
Methodology: https://510kreport.com/methodology