K-number	K152464
Device name	ORAcollect.Dx
Applicant	DNA Genotek, Inc.
Product code	OYJ
Device class	Class II
Decision date	May 26, 2016
Decision	Substantially Equivalent
Regulation	862.1675

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Source

View the full FDA submission: accessdata.fda.gov

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ORAcollect.Dx

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