PYP · Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | PYP |
|---|---|
| Device Name | Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161679 | s LDL-EX SEIKEN | Denka Seiken Co., Ltd. | Aug 18, 2017 | SESE |
Top Applicants
- Denka Seiken Co., Ltd. — 1 clearance
