Oragene®•Dx

Dna Specimen Collection, Saliva

DNA Genotek Inc.

The following data is part of a premarket notification filed by Dna Genotek Inc. with the FDA for Oragene®•dx.

Pre-market Notification Details

• Device ID: K192920
• 510k Number: K192920
• Device Name: Oragene®•Dx
• Classification: Dna Specimen Collection, Saliva
• Applicant: DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa, CA K2v 1c2
• Contact: Austin Udocor
• Correspondent: Austin Udocor; DNA Genotek Inc. 3000 - 500 Palladium Drive Ottawa, CA K2v 1c2
• Product Code: OYJ
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-16
• Decision Date: 2020-01-14