| Device Type ID | 2876 |
| Device Name | Immunochemical, Ceruloplasmin |
| Regulation Description | Ceruloplasmin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 866.5210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CHN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2876 |
| Device | Immunochemical, Ceruloplasmin |
| Product Code | CHN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ceruloplasmin Immunological Test System. |
| CFR Regulation Number | 866.5210 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CSL Behring GmbH | II | Nov-30-2017 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | Nov-28-2017 |