PSU · Class II · 21 CFR 866.6070

FDA Product Code PSU: Jak2 Gene Mutation Detection Test

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.

2
Total
1
Cleared
219d
Avg days
2017
Since

FDA 510(k) Cleared Jak2 Gene Mutation Detection Test Devices (Product Code PSU)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code PSU - Regulatory Context