DeviceClearance

Product code PSL— Clinical Chemistry

Vitamin D 200M Assay for the Topaz System

Classification name
25-Oh-Vitamin D Mass Spectrometry Test System
Device class
Class 2
Regulation
21 CFR 862.1840
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PSL under 21 CFR 862.1840, via openFDA

Market context for product code PSL

FDA has cleared 1 device under product code PSL, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PSL

Recent clearances under product code PSL

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