PYP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- FDA definition
- For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| s LDL-EX SEIKEN (K161679) | Denka Seiken Co., Ltd. | 2017-08-18 |
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Every clearance here is in the API, with alerts when new ones post.