510(k) DEN170019

Vitamin D 200M Assay for the Topaz System by Ab Sciex, LLC — Product Code PSL

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 18, 2017
Date Received: March 20, 2017
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: 25-Oh-Vitamin D Mass Spectrometry Test System
Device Class: Class II
Regulation Number: 862.1840
Review Panel: CH
Submission Type

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.