K-number	K211748
Device name	Selux AST System; Model AST Gen 1.0
Applicant	Selux Diagnostics, Inc.
Product code	LON
Device class	Class II
Decision date	Apr 19, 2023
Decision	Substantially Equivalent
Regulation	866.1645

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View the full FDA submission: accessdata.fda.gov

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Selux AST System; Model AST Gen 1.0

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