PYP — Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test Class I

FDA Device Classification

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-NumberApplicantDevice NameDate
K161679denka seiken cos LDL-EX SEIKENAugust 18, 2017