THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT— 510(k) K041657

Name: FDA 510(k) clearance K041657
Creator: U.S. Food and Drug Administration
Published: 2004-08-30

Substantially Equivalent

Thermo Electron Corporation

FDA 510(k) clearance K041657 for THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT, Substantially Equivalent on 2004-08-30. Applicant: Thermo Electron Corporation. Device class: 2.

Clearance details

Applicant: Thermo Electron Corporation
Product code: Code KQN
Device class: Class 2
Regulation: 21 CFR 862.1090
Advisory panel: Clinical Chemistry
Date received: 2004-06-18
Decision date: 2004-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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