K-number	K163225
Device name	AFIAS iFOB with AFIAS-50
Applicant	Immunostics Inc.,
Product code	OOX
Device class	Class II
Decision date	Aug 8, 2017
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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AFIAS iFOB with AFIAS-50

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