K-number	K163554
Device name	hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
Applicant	Immunostics Inc.,
Product code	KHE
Device class	Class II
Decision date	Jan 17, 2017
Decision	Substantially Equivalent
Regulation	864.6550

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View the full FDA submission: accessdata.fda.gov

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hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

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