The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Ceruloplasmin, Model 2055953.
| Device ID | K062114 |
| 510k Number | K062114 |
| Device Name: | CERULOPLASMIN, MODEL 2055953 |
| Classification | Immunochemical, Ceruloplasmin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | CHN |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2007-01-31 |
| Summary: | summary |