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 | ||
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Manufacturer | Decision | |
DIADEXUS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |