K-number	DEN170019
Device name	Vitamin D 200M Assay for the Topaz System
Applicant	Ab Sciex, LLC
Product code	PSL
Device class	Class II
Decision date	May 18, 2017
Decision	Not Substantially Equivalent
Regulation	862.1840

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View the full FDA submission: accessdata.fda.gov

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Vitamin D 200M Assay for the Topaz System

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