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 | Apr 22, 2024 |
| K183088 | Axis-Shield Diagnostics Limited | ADVIA Centaur Erythropoietin (EPO) assay | Aug 2, 2019 |
| K052223 | Beckman Coulter | ACCESS EPO ASSAY | Oct 6, 2006 |
| K992799 | Sangui Biotech | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | Jun 7, 2000 |
| K983203 | Diagnostic Products | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 | Jul 12, 1999 |
| K980737 | Nichols Institute Diagnostics | ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY | Mar 23, 1999 |
| K952559 | Nichols Institute | ERYTHROPOIETIN IMMUNOASSAY KIT | May 29, 1996 |
| K954898 | Genzyme | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) | Feb 5, 1996 |
| K936016 | R And D Systems | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | Jul 19, 1994 |
| K931756 | R And D Systems | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS | Apr 21, 1994 |
| K932650 | Nichols Institute | ERYTHROPOIETIN IMMUNOASSAY KIT | Mar 11, 1994 |
| K931666 | R And D Systems | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY | Jul 20, 1993 |
| K926390 | Genzyme | PREDICTA ERYTHROPOIETIN KIT | Jun 25, 1993 |
| K910481 | Ramco Laboratories | EPO-RIA | Nov 29, 1991 |
| K903492 | Diagnostic Systems Laboratories | DSL ERYTHROPOIETIN (DSL # 1100) | Oct 26, 1990 |
| K902639 | Incstar | EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA) | Aug 22, 1990 |
| K893393 | Incstar | EPO-TRAC BY RADIOIMMUNOASSAY (RIA) | Nov 21, 1989 |
| K894943 | Amgen | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 | Oct 10, 1989 |
| K882686 | Amgen | ERYTHROPOIETIN ENZYME IMMUNOASSAY | Dec 20, 1988 |
| K833957 | Jcl Clinical Research | ERYTHROPOIETIN EIA | Mar 23, 1984 |