# K061320: R&D LH-NRBC Hematology Control

- Pathway: 510(k) (Special)
- Applicant: R&D Systems, Inc.
- Decided: Jun 2, 2006 after 22 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: 2 generations back to K934497 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983032: CBC-5D Hematology Control, R&D Systems, Inc. (1999) Summary page 1.

## Indications for use
R&D LH-nRBC Hematology Control is a tr-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.

Source page: https://510kreport.com/device/K061320
Methodology: https://510kreport.com/methodology