K-number	K173212
Device name	Instant-view-PLUS immunochemical Fecal Occult Blood Test
Applicant	Alfa Scientific Designs, Inc.
Product code	KHE
Device class	Class II
Decision date	Feb 15, 2018
Decision	Substantially Equivalent
Regulation	864.6550

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Source

View the full FDA submission: accessdata.fda.gov

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Instant-view-PLUS immunochemical Fecal Occult Blood Test

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