DDR · Class II · 21 CFR 866.5680

FDA Product Code DDR: Myoglobin, Antigen, Antiserum, Control

Leading manufacturers include Beckman Coulter, Inc..

46
Total
46
Cleared
76d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Myoglobin, Antigen, Antiserum, Control Devices (Product Code DDR)

46 devices
1–24 of 46
Cleared Sep 18, 2023
Access Myoglobin
K231832
Beckman Coulter, Inc.
Chemistry · 88d

About Product Code DDR - Regulatory Context

510(k) Submission Activity

46 total 510(k) submissions under product code DDR since 1977, with 46 receiving FDA clearance (average review time: 76 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

DDR devices are reviewed by the Chemistry panel. Browse all Chemistry devices →