K-number	K920274
Device name	DIRECTIGEN NEISSERIA MENINGITIDIS TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTI
Device class	Class II
Decision date	Mar 18, 1992
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN NEISSERIA MENINGITIDIS TEST

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