# K061412: Thermo Electron Enzymatic Creatinine, Model TR35401

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron Corp.
- Decided: Mar 23, 2007 after 305 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
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 Thermo Electron Enzymatic Creatinine reagent is intended for the in vitro. quantitative determination of Creatinine in human serum, plasma or urine. Creatinine determinations are used in the diagnosis and treatment of renal impairment, in monitoring renal dialysis, and as a caltulation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K061412
Methodology: https://510kreport.com/methodology