GGT · Class II · 21 CFR 864.7250

FDA Product Code GGT: Assay, Erythropoietin

Leading manufacturers include R&D Systems, Inc., Beckman Coulter, Inc. and Incstar 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
1–20 of 20
Cleared Apr 22, 2024
Access EPO
K240182
Beckman Coulter, Inc.
Hematology · 90d
Cleared Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
K183088
Axis-Shield Diagnostics Limited
Hematology · 269d
Cleared Oct 06, 2006
ACCESS EPO ASSAY
K052223
Beckman Coulter, Inc.
Hematology · 417d
Cleared Jun 07, 2000
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
K992799
Sangui Biotech, Inc.
Hematology · 293d
Cleared Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
K983203
Diagnostic Products Corp.
Hematology · 301d
Cleared Mar 23, 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
K980737
Nichols Institute Diagnostics
Hematology · 391d
Cleared May 29, 1996
ERYTHROPOIETIN IMMUNOASSAY KIT
K952559
Nichols Institute
Hematology · 362d
Cleared Feb 05, 1996
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
K954898
Genzyme Corp.
Hematology · 138d
Cleared Jul 19, 1994
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
K936016
R&D Systems, Inc.
Hematology · 215d
Cleared Apr 21, 1994
QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS
K931756
R&D Systems, Inc.
Hematology · 378d
Cleared Jul 20, 1993
QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY
K931666
R&D Systems, Inc.
Hematology · 105d
Cleared Jun 25, 1993
PREDICTA ERYTHROPOIETIN KIT
K926390
Genzyme Corp.
Hematology · 185d
Cleared Oct 26, 1990
DSL ERYTHROPOIETIN (DSL # 1100)
K903492
Diagnostic Systems Laboratories, Inc.
Hematology · 84d
Cleared Aug 22, 1990
EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
K902639
Incstar Corp.
Hematology · 69d
Cleared Nov 21, 1989
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393
Incstar Corp.
Chemistry · 204d

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.