| Device Type ID | 364 |
| Device Name | Bromcresol Purple 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 | CJW |
| 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 | 364 |
| Device | Bromcresol Purple Dye-binding, Albumin |
| Product Code | CJW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Albumin Test System. |
| CFR Regulation Number | 862.1035 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 11 |
Low Test Results | 10 |
Tube | 4 |
Probe | 4 |
Mechanical Problem | 3 |
Diaphragm | 3 |
Pump | 2 |
Device Subassembly | 1 |
Incorrect Or Inadequate Test Results | 1 |
Valve | 1 |
Nozzle | 1 |
Washer | 1 |
Nozzle Tip | 1 |
| Total Device Problems | 43 |