K-number	K143236
Device name	Theranos Herpes Simplex Virus-1 IgG Assay
Applicant	Theranos, Inc.
Product code	MXJ
Device class	Class II
Decision date	Jul 2, 2015
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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Theranos Herpes Simplex Virus-1 IgG Assay

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