CHN · Immunochemical, Ceruloplasmin
Immunology · 21 CFR 866.5210 · Class 2
Overview
| Product Code | CHN |
|---|---|
| Device Name | Immunochemical, Ceruloplasmin |
| Regulation | 21 CFR 866.5210 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091741 | TINA-QUANT CERULOPLASMIN | Roche Diagnostics | Mar 18, 2010 | SESE |
| K063655 | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | Feb 15, 2007 | SESE |
| K062114 | CERULOPLASMIN, MODEL 2055953 | Roche Diagnostics Corp. | Jan 31, 2007 | SESE |
Top Applicants
- Roche Diagnostics Corp. — 1 clearance
- Roche Diagnostics — 1 clearance
- Dade Behring, Inc. — 1 clearance
