K-number	K860768
Device name	DIRECTIGEN COMBO MENINGITIS TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTZ
Device class	Class I
Decision date	May 13, 1986
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN COMBO MENINGITIS TEST

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