OXALATE URINE CONTROLS (NORMAL AND ELEVATED)— 510(k) K062521

Name: FDA 510(k) clearance K062521
Creator: U.S. Food and Drug Administration
Published: 2007-03-16

Substantially Equivalent

Thermo-Electron Corp.

FDA 510(k) clearance K062521 for OXALATE URINE CONTROLS (NORMAL AND ELEVATED), Substantially Equivalent on 2007-03-16. Applicant: Thermo-Electron Corp.. Device class: 2.

Clearance details

Applicant: Thermo-Electron Corp.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2006-08-28
Decision date: 2007-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noble Park, AU

Download summary PDF View on FDA.gov ↗

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