FDA Product Code GGT: Assay, Erythropoietin
Leading manufacturers include Beckman Coulter, Inc..
20
Total
20
Cleared
222d
Avg days
1984
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Assay, Erythropoietin Devices (Product Code GGT)
20 devices
About Product Code GGT - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code GGT since 1984, with 20 receiving FDA clearance (average review time: 222 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
GGT devices are reviewed by the Hematology panel. Browse all Hematology devices →