K-number	K172126
Device name	Xpert Xpress Strep A
Applicant	Cepheid
Product code	PGX
Device class	Class II
Decision date	Sep 25, 2017
Decision	Substantially Equivalent
Regulation	866.2680

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Source

View the full FDA submission: accessdata.fda.gov

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Xpert Xpress Strep A

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