The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Predicta Erythropoietin Kit.
| Device ID | K926390 |
| 510k Number | K926390 |
| Device Name: | PREDICTA ERYTHROPOIETIN KIT |
| 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 | 1992-12-22 |
| Decision Date | 1993-06-25 |