ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500— 510(k) K110701

Name: FDA 510(k) clearance K110701
Creator: U.S. Food and Drug Administration
Published: 2011-12-02

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K110701 for ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500, Substantially Equivalent on 2011-12-02. Applicant: DNA Genotek, Inc.. Device class: 2.

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Device class: Class 2
Regulation: 21 CFR 862.1675
Advisory panel: Clinical Chemistry
Date received: 2011-03-14
Decision date: 2011-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa Ontario, CA

Download summary PDF View on FDA.gov ↗

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