510(k) K192920
K192920 is an FDA 510(k) premarket notification submitted by DNA Genotek, Inc. for the device "Oragene®Dx". The FDA issued a decision of Substantially Equivalent on Jan 14, 2020. The device falls under product code OYJ (Dna Specimen Collection, Saliva), a Class II device regulated under 21 CFR 862.1675. DNA Genotek, Inc. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 14, 2020
- Date Received
- Oct 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dna Specimen Collection, Saliva
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type
- 510(k)
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.