# K984099: QBC Centrifugal Hematology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Dec 10, 1998 after 23 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 K954137 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954137: QBC Centrifugal Hematology Control, R&D Systems, Inc. (1995) Summary page 1.

## Indications for use
QBC Centrifugal Hematology Control is intended as a quality control for QBC+, QBC II, QBC II Plus, QBC Reference and QBC AUTOREAD centrifugal hematology systems, to monitor hematocrit, hemoglobin, white blood cell count, granulocyte count, lymphocyte/monocyte count, and platelet count.

Source page: https://510kreport.com/device/K984099
Methodology: https://510kreport.com/methodology