510(k) DEN160028
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 27, 2017
- Date Received
- July 1, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Jak2 Gene Mutation Detection Test
- Device Class
- Class II
- Regulation Number
- 866.6070
- Review Panel
- PA
- Submission Type
The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.