PYP — Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test Class I
FDA product code PYP covers "Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test", a Class I medical device regulated under 21 CFR 862.1475. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PYP
- Device Class
- Class I
- Regulation Number
- 862.1475
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Definition
For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161679 | denka seiken co | s LDL-EX SEIKEN | August 18, 2017 |