ORAcollect.Dx— 510(k) K152464

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K152464 for ORAcollect.Dx, Substantially Equivalent on 2016-05-26. Applicant: DNA Genotek, Inc..

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Advisory panel: Clinical Chemistry
Date received: 2015-08-31
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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