# K033056: Bun Reagent for Beckman Synchron CX & CX Delta Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Jan 30, 2004 after 123 days
- Product code: CDS (Electrode, Ion Specific, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 K864236 (1986). 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)
- K942676: Synchron CX3 Delta, Beckman-Diagnostic Systems Group (1994) Summary page 1.
- K864236: Synchron CX3, Beckman Instruments, Inc. (1986) Summary page 1.

## Indications for use
Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of blood urea nitrogen (BUN) in serum, plasma, and urine on Beckman Synchron CX® & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases

Source page: https://510kreport.com/device/K033056
Methodology: https://510kreport.com/methodology