Name: Predicase
Price: 199 USD

K-number	K181665
Device name	BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
Applicant	Becton, Dickinson and Company
Product code	LON
Device class	Class II
Decision date	Sep 21, 2018
Decision	Substantially Equivalent
Regulation	866.1645

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Source

View the full FDA submission: accessdata.fda.gov

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BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN

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