Definition: The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, Is Intended To Measure Lipoprotein-associated Phospholipase A2 In Human Plasma In Conjunction With Clinical Evaluation And Other Patient Risk Factors Including Biochemical Analys
| Device Type ID | 3065 |
| Device Name | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Regulation Description | Low-density Lipoprotein Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NOE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3065 |
| Device | Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 |
| Product Code | NOE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Low-density Lipoprotein Immunological Test System. |
| CFR Regulation Number | 866.5600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DIADEXUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |