| Device Type ID | 2924 |
| Device Name | Albumin, Antigen, Antiserum, Control |
| Regulation Description | Albumin 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 | 866.5040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DCF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2924 |
| Device | Albumin, Antigen, Antiserum, Control |
| Product Code | DCF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Albumin Immunological Test System. |
| CFR Regulation Number | 866.5040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER IRELAND INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THE BINDING SITE GROUP LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Low Test Results | 2 |
Incorrect Or Inadequate Test Results | 2 |
Device Ingredient Or Reagent | 1 |
Non Reproducible Results | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-22-2017 |