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 |