NVI · Class II · 21 CFR 862.3100

FDA Product Code NVI: Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease

The Device Is Intended To Suggest A Systemic Autoimmune Disease Association As An Aid For Differential Diagnosis To Be Evaluated In Conjunction With Clinical Findings And Other Laboratory Tests.

1
Total
1
Cleared
328d
Avg days
2005
Since

FDA 510(k) Cleared Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease Devices (Product Code NVI)

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

About Product Code NVI - Regulatory Context