K-number	K180006
Device name	AmCAD-UT Detection 2.2
Applicant	Amcad Biomed Corporation
Product code	LLZ
Device class	Class II
Decision date	Aug 31, 2018
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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AmCAD-UT Detection 2.2

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