510(k) DEN160028
DEN160028 is an FDA 510(k) premarket notification submitted by Qiagen, Inc. for the device "ipsogen JAK2 RGQ PCR Kit". The FDA issued a decision of De Novo Granted on March 27, 2017. The device falls under product code PSU (Jak2 Gene Mutation Detection Test), a Class II device regulated under 21 CFR 866.6070. Qiagen, Inc. has at least 10 other 510(k) clearances on record.
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.