DeviceClearance

Product code PYP— Clinical Chemistry

s LDL-EX SEIKEN

Classification name
Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test
Device class
Class 1
Regulation
21 CFR 862.1475
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

FDA classification definition

“For the quantitative determination of low-density lipoprotein (LDL) cholesterol sub-fractions.”

— U.S. Food and Drug Administration, device classification record for product code PYP under 21 CFR 862.1475, via openFDA

Market context for product code PYP

FDA has cleared 1 device under product code PYP, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PYP

Recent clearances under product code PYP

Data sourced from openFDA. This site is unofficial and independent of the FDA.