510(k) K110701
K110701 is an FDA 510(k) premarket notification submitted by DNA Genotek, Inc. for the device "ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500". The FDA issued a decision of Substantially Equivalent on December 2, 2011. 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 at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2011
- Date Received
- March 14, 2011
- 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
A collection device intended for use in the non-invasive collection of saliva samples for clinical dna testing.