Immunochemical, Ceruloplasmin
The Immunochemical, Ceruloplasmin test system (product code CHN) is an in-vitro diagnostic device used in immunology to measure ceruloplasmin, a copper-carrying protein, in serum using immunochemical methods, supporting the diagnosis of Wilson's disease, Menkes disease, and copper metabolism disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 866.5210 in the Immunology medical specialty.
Basic Information
- Product Code
- CHN
- Device Class
- FDA class 2
- Regulation Number
- 866.5210
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091741 | TINA-QUANT CERULOPLASMIN | Mar 18, 2010 | Substantially Equivalent | Roche Diagnostics |
| K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | Feb 15, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K062114 | CERULOPLASMIN, MODEL 2055953 | Jan 31, 2007 | Substantially Equivalent | Roche Diagnostics Corp. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.