FDA 510(k) Applications for Medical Device Product Code "GGT"
(Assay, Erythropoietin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K183088 | Axis-Shield Diagnostics Limited | ADVIA Centaur Erythropoietin (EPO) assay | 08/02/2019 |
| K052223 | BECKMAN COULTER, INC. | ACCESS EPO ASSAY | 10/06/2006 |
| K983203 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | 07/12/1999 |
| K954898 | GENZYME CORP. | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | 02/05/1996 |
| K952559 | NICHOLS INSTITUTE | ERYTHROPOIETIN IMMUNOASSAY KIT | 05/29/1996 |
| K980737 | NICHOLS INSTITUTE DIAGNOSTICS | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | 03/23/1999 |
| K992799 | SANGUI BIOTECH, INC. | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | 06/07/2000 |
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