EON CHOLESTEROL REAGENT— 510(k) K120202

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..

Clearance details

Applicant: Vital Diagnostics Pty., Ltd.
Product code: Code CHH
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 ↗

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