510(k) K192947
K192947 is an FDA 510(k) premarket notification submitted by Ancestry Genomics, Inc. for the device "AncestryDNA Saliva Collection Kit". The FDA issued a decision of Substantially Equivalent on Aug 13, 2020. The device falls under product code OYJ (Dna Specimen Collection, Saliva), a Class II device regulated under 21 CFR 862.1675. Ancestry Genomics, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2020
- Date Received
- Oct 18, 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.