GGT — Assay, Erythropoietin Class II
FDA product code GGT covers "Assay, Erythropoietin", a Class II medical device regulated under 21 CFR 864.7250. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGT
- Device Class
- Class II
- Regulation Number
- 864.7250
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240182 | beckman coulter | Access EPO | April 22, 2024 |
| K183088 | axis-shield diagnostics limited | ADVIA Centaur Erythropoietin (EPO) assay | August 2, 2019 |
| K052223 | beckman coulter | ACCESS EPO ASSAY | October 6, 2006 |
| K992799 | sangui biotech | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | June 7, 2000 |
| K983203 | diagnostic products | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | July 12, 1999 |
| K980737 | nichols institute diagnostics | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | March 23, 1999 |
| K952559 | nichols institute | ERYTHROPOIETIN IMMUNOASSAY KIT | May 29, 1996 |
| K954898 | genzyme | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | February 5, 1996 |
| K936016 | r and d systems | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | July 19, 1994 |
| K931756 | r and d systems | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | April 21, 1994 |
| K932650 | nichols institute | ERYTHROPOIETIN IMMUNOASSAY KIT | March 11, 1994 |
| K931666 | r and d systems | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | July 20, 1993 |
| K926390 | genzyme | PREDICTA ERYTHROPOIETIN KIT | June 25, 1993 |
| K910481 | ramco laboratories | EPO-RIA | November 29, 1991 |
| K903492 | diagnostic systems laboratories | DSL ERYTHROPOIETIN (DSL # 1100) | October 26, 1990 |
| K902639 | incstar | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) | August 22, 1990 |
| K893393 | incstar | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) | November 21, 1989 |
| K894943 | amgen | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 | October 10, 1989 |
| K882686 | amgen | ERYTHROPOIETIN ENZYME IMMUNOASSAY | December 20, 1988 |
| K833957 | jcl clinical research | ERYTHROPOIETIN EIA | March 23, 1984 |