| Device Type ID | 2928 |
| Device Name | System, Test, C-reactive Protein |
| 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 | DCN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2928 |
| Device | System, Test, C-reactive Protein |
| Product Code | DCN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | C-reactive Protein Immunological Test System. |
| CFR Regulation Number | 866.5270 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
THE BINDING SITE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE GROUP LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 13 |
High Test Results | 10 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Incorrect Or Inadequate Test Results | 2 |
Insufficient Information | 1 |
Probe | 1 |
Mechanical Problem | 1 |
Cups | 1 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 35 |