| Device Type ID | 2873 |
| Device Name | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Regulation Description | Immunoglobulins A, G, M, D, And E 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 | 866.5510 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CFN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2873 |
| Device | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Product Code | CFN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immunoglobulins A, G, M, D, And E Immunological Test System. |
| CFR Regulation Number | 866.5510 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE GROUP LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 3 |
High Test Results | 2 |
Low Test Results | 2 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | III | Mar-17-2015 |
| 2 | The Binding Site Group, Ltd. | II | Dec-13-2018 |
| 3 | The Binding Site Group, Ltd. | II | Nov-17-2018 |
| 4 | The Binding Site Group, Ltd. | III | Jul-27-2017 |
| 5 | The Binding Site Group, Ltd. | II | Jan-23-2017 |