# K992847: Hichem Bun Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Elan Holdings, Inc.
- Decided: Oct 14, 1999 after 51 days
- Product code: LFP (Conductivity Rate, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SYNCHRON® CX® Systems BUN Reagent Kit, product no. 443350: named in the summary without a submission number

## Indications for use
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases. This reagent is intended for professional use only.

Source page: https://510kreport.com/device/K992847
Methodology: https://510kreport.com/methodology