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 |