K-number	K132822
Device name	BD MAX STAPHSR ASSAY, INSTRUMENT
Applicant	Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Product code	NQX
Device class	Class II
Decision date	Nov 26, 2013
Decision	Substantially Equivalent
Regulation	866.1640

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View the full FDA submission: accessdata.fda.gov

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BD MAX STAPHSR ASSAY, INSTRUMENT

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