Product code PSU— Medical Genetics
ipsogen JAK2 RGQ PCR Kit
- Classification name
- Jak2 Gene Mutation Detection Test
- Device class
- Class 2
- Regulation
- 21 CFR 866.6070
- Advisory panel
- Medical Genetics
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code PSU
FDA has cleared devices under product code PSU between 2017 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2017
Top applicants under product code PSU
Recent clearances under product code PSU
Data sourced from openFDA. This site is unofficial and independent of the FDA.