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.

Leading manufacturers include Bio-Rad Laboratories, Inc..

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
Cleared Oct 27, 2005
BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K043341
Bio-Rad Laboratories, Inc.
Immunology · 328d

About Product Code NVI - Regulatory Context