# K060083: NRBC-Chex for LH

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Feb 9, 2006 after 29 days
- Product code: GJR (Control, Red-Cell)
- 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 K000945 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000945: Para 12 Plus Retics, Streck Laboratories, Inc. (2000) Summary page 1.

## Most influential descendants
- K080016: NRBC-Chex for Advia (2008), 0 descendants of its own

## Indications for use
nRBC-Chex for LH is an assayed whole blood control designed to evaluate the accuracy and precision of the Beckman Coulter® LH 750 in its measurement of the nucleated red blood cell parameter.

Source page: https://510kreport.com/device/K060083
Methodology: https://510kreport.com/methodology