K-number	K172509
Device name	Sentosa SA201 HSV 1/2 Qualitative PCR Test
Applicant	Vela Diagnostics USA, Inc.
Product code	OQO
Device class	Class II
Decision date	Feb 1, 2018
Decision	Substantially Equivalent
Regulation	866.3305

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Source

View the full FDA submission: accessdata.fda.gov

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Sentosa SA201 HSV 1/2 Qualitative PCR Test

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