Name: Predicase
Price: 199 USD

K-number	K870155
Device name	DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	GTZ
Device class	Class I
Decision date	Mar 10, 1987
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST

Everything you need for a 510(k) submission. Nothing you don't.