# K041052: Raichem Glucose UV (Liquid)

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jun 30, 2004 after 72 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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 intended for the quantitative enzymatic determination of glucose in serum or plasma. For in vitro diagnostic use only. This glucose test system is a device intended to measure glucose quantitatively in serum or plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell tumors. The intended patient population may be adult, pediatric, and neonatal.

Source page: https://510kreport.com/device/K041052
Methodology: https://510kreport.com/methodology