| Device Type ID | 3002 |
| Device Name | System, Test, Rheumatoid Factor |
| Regulation Description | Rheumatoid Factor 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 | 866.5775 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DHR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3002 |
| Device | System, Test, Rheumatoid Factor |
| Product Code | DHR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rheumatoid Factor Immunological Test System. |
| CFR Regulation Number | 866.5775 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMMCO DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHADIA AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE GROUP, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2 |
Probe | 1 |
Low Test Results | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 5 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Stanbio Laboratory, LP | II | Mar-15-2018 |
| 2 | The Binding Site Group, Ltd. | II | Feb-08-2018 |