K-number	K150962
Device name	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
Applicant	Focus Diagnostics
Product code	OQO
Device class	Class II
Decision date	Aug 28, 2015
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

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