The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Predicta Erythropoietin Kit (modification).
| Device ID | K954898 |
| 510k Number | K954898 |
| Device Name: | PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) |
| Classification | Assay, Erythropoietin |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Alodia M Ruiz |
| Correspondent | Alodia M Ruiz GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-20 |
| Decision Date | 1996-02-05 |