# K050283: Creatinine Liquicolor

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Jun 30, 2005 after 143 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941837 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941837: Roche Reagent for Creatinine, Roche Diagnostic Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K161527: Teco Creatinine Enzymatic Reagent Kit (2017), 0 descendants of its own

## Indications for use
The Stanbio Creatinine LiquiColor® test system is a device intended to measure creatinine levels in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K050283
Methodology: https://510kreport.com/methodology