| Device Type ID | 2927 |
| Device Name | C-reactive Protein, Antigen, Antiserum, And Control |
| Regulation Description | C-reactive Protein 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) |
| CFR Regulation Number | 866.5270 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DCK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2927 |
| Device | C-reactive Protein, Antigen, Antiserum, And Control |
| Product Code | DCK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | C-reactive Protein Immunological Test System. |
| CFR Regulation Number | 866.5270 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORION DIAGNOSTICA OY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUALIGEN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtest Holdings, Inc. | III | Jun-26-2017 |
| 2 | Ortho-Clinical Diagnostics | III | Dec-21-2016 |