510(k) K172287
K172287 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 Substantially Equivalent on Jan 12, 2018. 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 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2018
- Date Received
- Jul 28, 2017
- Clearance Type
- Traditional
- 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
- 510(k)
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.