# K161679: s LDL-EX SEIKEN

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken Co., Ltd.
- Decided: Aug 18, 2017 after 427 days
- Product code: PYP (Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

Source page: https://510kreport.com/device/K161679
Methodology: https://510kreport.com/methodology