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 |