CHN — Immunochemical, Ceruloplasmin Class II
FDA product code CHN covers "Immunochemical, Ceruloplasmin", a Class II medical device regulated under 21 CFR 866.5210. Submissions are reviewed by the Immunology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CHN
- Device Class
- Class II
- Regulation Number
- 866.5210
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K091741 | roche diagnostics | TINA-QUANT CERULOPLASMIN | March 18, 2010 |
| K063655 | dade behring | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CON | February 15, 2007 |
| K062114 | roche diagnostics | CERULOPLASMIN, MODEL 2055953 | January 31, 2007 |