FDA Product Code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Leading manufacturers include Zeus Scientific, Inc..
110
Total
110
Cleared
67d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DHN)
110 devices
About Product Code DHN - Regulatory Context
510(k) Submission Activity
110 total 510(k) submissions under product code DHN since 1976, with 110 receiving FDA clearance (average review time: 67 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
DHN devices are reviewed by the Immunology panel. Browse all Immunology devices →