# K042421: Uritek 151 Urine Analyzer, Model TC-151

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: May 9, 2005 after 244 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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
The Uritek-151 Urine Analyzer is intended for use with Teco Urine Reagent Strips for Urinalysis such URS-10, used in the determination of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in uriwe.

Source page: https://510kreport.com/device/K042421
Methodology: https://510kreport.com/methodology