The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Tina-quant Ceruloplasmin.
| Device ID | K091741 |
| 510k Number | K091741 |
| Device Name: | TINA-QUANT CERULOPLASMIN |
| Classification | Immunochemical, Ceruloplasmin |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Kathie J Goodwin |
| Correspondent | Kathie J Goodwin Roche Diagnostics 9115 Hague Road 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 | 2009-06-16 |
| Decision Date | 2010-03-18 |
| Summary: | summary |