K-number	K180559
Device name	HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
Applicant	Elitechgroup
Product code	PGI
Device class	Class II
Decision date	Oct 29, 2018
Decision	Substantially Equivalent
Regulation	866.3309

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Source

View the full FDA submission: accessdata.fda.gov

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HSV 1 & 2 ELITe MGB Kit; ELITe InGenius

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