# K012649: Raichem Bun Rate Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Oct 15, 2001 after 63 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 (BUN) in serum or plasma. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K012649
Methodology: https://510kreport.com/methodology