THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401— 510(k) K061412

Name: FDA 510(k) clearance K061412
Creator: U.S. Food and Drug Administration
Published: 2007-03-23

Substantially Equivalent

Thermo Electron Corp.

FDA 510(k) clearance K061412 for THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401, Substantially Equivalent on 2007-03-23. Applicant: Thermo Electron Corp.. Device class: 2.

Clearance details

Applicant: Thermo Electron Corp.
Product code: Code JFY
Device class: Class 2
Regulation: 21 CFR 862.1225
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 ↗

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