Name: Predicase
Price: 199 USD

K-number	K893753
Device name	DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	LHK
Device class	Class II
Decision date	Oct 16, 1989
Decision	Substantially Equivalent
Regulation	866.3165

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Source

View the full FDA submission: accessdata.fda.gov

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DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

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