| Device Type ID | 3020 |
| Device Name | Nephelometer |
| Regulation Description | Immunonephelometer Equipment. |
| 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 | 866.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JZW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3020 |
| Device | Nephelometer |
| Product Code | JZW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Immunonephelometer Equipment. |
| CFR Regulation Number | 866.4540 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
High Test Results | 4 |
Low Test Results | 3 |
Incorrect Or Inadequate Test Results | 2 |
Mechanical Problem | 1 |
| Total Device Problems | 17 |