The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for N-geneous Wide Range Crp Reagent And Calibrator Set.
| Device ID | K040241 |
| 510k Number | K040241 |
| Device Name: | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Contact | Fred D Lasky |
| Correspondent | Fred D Lasky GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-03 |
| Decision Date | 2004-06-25 |
| Summary: | summary |