K-number	DEN220028
Device name	Cue COVID-19 Molecular Test
Applicant	Cue Health, Inc.
Product code	QWB
Device class	Class II
Decision date	Jun 6, 2023
Decision	Not Substantially Equivalent
Regulation	866.3984

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Source

View the full FDA submission: accessdata.fda.gov

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Cue COVID-19 Molecular Test

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