K-number	K190219
Device name	Simplexa VZV Direct, Simplexa VZV Positive Control Pack
Applicant	Diasorin Molecular, LLC
Product code	PLO
Device class	Class II
Decision date	May 13, 2019
Decision	Substantially Equivalent
Regulation	866.3970

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa VZV Direct, Simplexa VZV Positive Control Pack

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