# K954137: QBC Centrifugal Hematology Control

- Pathway: 510(k) (Traditional)
- Applicant: R&D Systems, Inc.
- Decided: Oct 6, 1995 after 35 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
- K993678: Thrombelastograph Coagulation Analyzer Teg - 5000 Series (2000), 1 descendant of its own
- K183160: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge (2019), 0 descendants of its own
- K984099: QBC Centrifugal Hematology Control (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K954137
Methodology: https://510kreport.com/methodology