K061412

Substantially Equivalent

THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401

Applicant: Thermo Electron Corp.
Product code: JFY
Advisory panel: Clinical Chemistry
Date received: 2006-05-22
Decision date: 2007-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburg, PA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.