EON CHOLESTEROL REAGENT— 510(k) K120202

Name: FDA 510(k) clearance K120202
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Substantially Equivalent

Vital Diagnostics Pty., Ltd.

FDA 510(k) clearance K120202 for EON CHOLESTEROL REAGENT, Substantially Equivalent on 2012-07-27. Applicant: Vital Diagnostics Pty., Ltd.. Device class: 1.

Clearance details

Applicant: Vital Diagnostics Pty., Ltd.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2012-01-23
Decision date: 2012-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Noble Park, AU

Download summary PDF View on FDA.gov ↗

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