510(k) K083171
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2008
- Date Received
- October 27, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Quality Control Material, Genetics, Dna
- Device Class
- Class II
- Regulation Number
- 866.5910
- Review Panel
- IM
- Submission Type
Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.