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

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..

Clearance details

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

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