K-number	K221688
Device name	ASTar BC G- Kit and ASTar Instrument
Applicant	Q-Linea AB
Product code	SAN
Device class	Class II
Decision date	Apr 26, 2024
Decision	Substantially Equivalent
Regulation	866.1650

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Source

View the full FDA submission: accessdata.fda.gov

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ASTar BC G- Kit and ASTar Instrument

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