PSL

25-Oh-Vitamin D Mass Spectrometry Test System

Product code: PSL
Device name: 25-Oh-Vitamin D Mass Spectrometry Test System
Device class: Class 2
21 CFR: 21 CFR 862.1840
Medical specialty: Clinical Chemistry
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A 25-OH-Vitamin D Mass Spectrometry test system is intended to for vitro diagnostic use in the quantitative determination of total 25-hydroxyvitamin D (25-OH-D)using mass spectrometry.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PSL

Classification and pathway per current FDA publications. Data from openFDA (CC0).