ORAcollect®Dx— 510(k) K212745

Substantially Equivalent

DNA Genotek, Inc.

FDA 510(k) clearance K212745 for ORAcollect®Dx, Substantially Equivalent on 2022-10-27. Applicant: DNA Genotek, Inc..

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code OYJ
Advisory panel: Clinical Chemistry
Date received: 2021-08-30
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

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