DBF · Class II · 21 CFR 866.5340

FDA Product Code DBF: Ferritin, Antigen, Antiserum, Control

Leading manufacturers include DiaSorin, Inc..

87
Total
87
Cleared
67d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Ferritin, Antigen, Antiserum, Control Devices (Product Code DBF)

87 devices
1–24 of 87
Cleared Sep 14, 2021
LIAISON Ferritin
K193650
DiaSorin, Inc.
Immunology · 624d

About Product Code DBF - Regulatory Context

510(k) Submission Activity

87 total 510(k) submissions under product code DBF since 1977, with 87 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.

DBF devices are reviewed by the Immunology panel. Browse all Immunology devices →