ORAGENE DX OGD-500.001— 510(k) K141410

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K141410 for ORAGENE DX OGD-500.001, Substantially Equivalent on 2015-02-19. Applicant: DNA Genotek, Inc..

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Advisory panel: Clinical Chemistry
Date received: 2014-05-29
Decision date: 2015-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

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