# K063390: Urine Chemistry Analyzer UR-50

- Pathway: 510(k) (Traditional)
- Applicant: Ind Diagnostic, Inc.
- Decided: Mar 1, 2007 after 112 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- 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
Urine Chemistry Analyzer UR-50 is for use with the IND Urinalysis Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite, leukocytes, pH, and specific gravity in urine. It can be used for testing in the clinical laboratory setting. For professional use only. These measurements are useful in the evaluation of renal, urinary, and metabolic disorders,

Source page: https://510kreport.com/device/K063390
Methodology: https://510kreport.com/methodology