Panels › Hematology › Product code GGT · Class 2
Assay, Erythropoietin
Regulation 864.7250
0510(k)s in 12 months (20 all time)
0recalls in 12 months (5 all time)
4recalls that name a 510(k)
Top companies in GGT
| Company | 510(k)s | Recalls |
|---|---|---|
| R&D Systems, Inc. | 3 | 1 |
| Beckman Coulter, Inc. | 2 | 1 |
| Amgen, Inc. | 2 | 0 |
| Genzyme Corp. | 2 | 0 |
| Incstar Corp. | 2 | 0 |
| Nichols Institute | 2 | 0 |
| Nichols Institute Diagnostics | 1 | 1 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Axis-Shield Diagnostics Limited | 1 | 0 |
| Diagnostic Products Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 2024 | K240182 | Access EPO Beckman Coulter, Inc. | GGT |
| Aug 2, 2019 | K183088 | ADVIA Centaur Erythropoietin (EPO) assay Axis-Shield Diagnostics Limited, GB | GGT |
| Oct 6, 2006 | K052223 | ACCESS EPO ASSAY Beckman Coulter, Inc. | GGT |
| Jun 7, 2000 | K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT Sangui Biotech, Inc. | GGT |
| Jul 12, 1999 | K983203 | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 Diagnostic Products Corp. | GGT |
| Mar 23, 1999 | K980737 | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY Nichols Institute Diagnostics | GGT |
| May 29, 1996 | K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute | GGT |
| Feb 5, 1996 | K954898 | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) Genzyme Corp. | GGT |
| Jul 19, 1994 | K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc. | GGT |
| Apr 21, 1994 | K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS R&D Systems, Inc. | GGT |
| Mar 11, 1994 | K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute | GGT |
| Jul 20, 1993 | K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY R&D Systems, Inc. | GGT |
| Jun 25, 1993 | K926390 | PREDICTA ERYTHROPOIETIN KIT Genzyme Corp. | GGT |
| Nov 29, 1991 | K910481 | EPO-RIA Ramco Laboratories, Inc. | GGT |
| Oct 26, 1990 | K903492 | DSL ERYTHROPOIETIN (DSL # 1100) Diagnostic Systems Laboratories, Inc. | GGT |
| Aug 22, 1990 | K902639 | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) Incstar Corp. | GGT |
| Nov 21, 1989 | K893393 | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) Incstar Corp. | GGT |
| Oct 10, 1989 | K894943 | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 Amgen, Inc. | GGT |
| Dec 20, 1988 | K882686 | ERYTHROPOIETIN ENZYME IMMUNOASSAY Amgen, Inc. | GGT |
| Mar 23, 1984 | K833957 | ERYTHROPOIETIN EIA Jcl Clinical Research Corp. | GGT |
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