# K041051: Raichem Bun Rate Reagent (Liquid)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 30, 2004 after 72 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This reagent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction. This urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The intended patient population may be adult, pediatric, and neonatal.

Source page: https://510kreport.com/device/K041051
Methodology: https://510kreport.com/methodology