| Device Type ID | 266 |
| Device Name | Biuret (colorimetric), Total Protein |
| Regulation Description | Total Protein 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) Exempt |
| CFR Regulation Number | 862.1635 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CEK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 266 |
| Device | Biuret (colorimetric), Total Protein |
| Product Code | CEK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Protein Test System. |
| CFR Regulation Number | 862.1635 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 2 |
Device Difficult To Setup Or Prepare | 1 |
Off-Label Use | 1 |
| Total Device Problems | 4 |