PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
Device Facts
| Record ID | K954898 |
|---|---|
| Device Name | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) |
| Applicant | Genzyme Corp. |
| Product Code | GGT · Hematology |
| Decision Date | Feb 5, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.
Special Controls
*Classification.* Class II. The special control for this device is FDA's “Document for Special Controls for Erythropoietin Assay Premarket Notification (510(k)s).”
