Name: Predicase
Price: 199 USD

K-number	K163085
Device name	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
Applicant	Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
Product code	OZN
Device class	Class II
Decision date	Feb 14, 2017
Decision	Substantially Equivalent
Regulation	866.3130

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Source

View the full FDA submission: accessdata.fda.gov

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Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

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