510(k) K063224
K063224 is an FDA 510(k) premarket notification submitted by Gentris Corporation for the device "GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code NZB (Quality Control Material, Genetics, Dna), a Class II device regulated under 21 CFR 866.5910.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- October 24, 2006
- 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.