FDA Product Code GGT: Assay, Erythropoietin
Leading manufacturers include Beckman Coulter, Inc., Axis-Shield Diagnostics Limited and Diagnostic Products Corp..
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
Cleared
Apr 22, 2024
Access EPO
Beckman Coulter, Inc.
Hematology
90d
Cleared
Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
Axis-Shield Diagnostics Limited
Hematology
269d
Cleared
Oct 06, 2006
ACCESS EPO ASSAY
Beckman Coulter, Inc.
Hematology
417d
Cleared
Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
Diagnostic Products Corp.
Hematology
301d
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.