The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator.
| Device ID | K080662 |
| 510k Number | K080662 |
| Device Name: | GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR |
| Classification | Test, Cystatin C |
| Applicant | GENZYME CORPORATION 31 NEW YORK AVENUE Framingham, MA 01701 -9322 |
| Contact | Eric Lawson |
| Correspondent | Eric Lawson GENZYME CORPORATION 31 NEW YORK AVENUE Framingham, MA 01701 -9322 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-05-15 |
| Summary: | summary |