K-number	K952791
Device name	DIRECTIGEN MENINGITIS COMBO TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTJ
Device class	Class II
Decision date	May 30, 1996
Decision	Substantially Equivalent
Regulation	866.3390

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View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN MENINGITIS COMBO TEST

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