K-number	K240408
Device name	REMI-AI Rapid Detection Module (REMI-AI RDM)
Applicant	Epitel, Inc.
Product code	OMB
Device class	Class II
Decision date	Oct 17, 2024
Decision	Substantially Equivalent
Regulation	882.1400

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Source

View the full FDA submission: accessdata.fda.gov

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REMI-AI Rapid Detection Module (REMI-AI RDM)

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