| Device Type ID | 343 |
| Device Name | Bromcresol Green Dye-binding, Albumin |
| Regulation Description | Albumin Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1035 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CIX |
| 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 | 343 |
| Device | Bromcresol Green Dye-binding, Albumin |
| Product Code | CIX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Albumin Test System. |
| CFR Regulation Number | 862.1035 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOSYSTEMS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Low Test Results | 7 |
Adverse Event Without Identified Device Or Use Problem | 2 |
High Test Results | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 11 |