Definition: For The Quantitative Determination Of Low-density Lipoprotein (LDL) Cholesterol Sub-fractions.
| Device Type ID | 675 |
| Device Name | Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test |
| Physical State | The Assay Uses Surfactants And Enzymes That React With Certain Groups Of Lipoproteins. |
| Technical Method | Quantitative Colorimetric Assay |
| Target Area | Human Serum Or Plasma. |
| Regulation Description | Lipoprotein 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) |
| CFR Regulation Number | 862.1475 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PYP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 675 |
| Device | Low-density Lipoprotein (ldl) Cholesterol Sub-fraction Test |
| Product Code | PYP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Lipoprotein Test System. |
| CFR Regulation Number | 862.1475 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DENKA SEIKEN CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |