K-number	K243070
Device name	Xpert® SA Nasal Complete
Applicant	Cepheid®
Product code	NQX
Device class	Class II
Decision date	Oct 25, 2024
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert® SA Nasal Complete

Everything you need for a 510(k) submission. Nothing you don't.