Name: Predicase
Price: 199 USD

K-number	K060324
Device name	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE
Applicant	Becton, Dickinson & CO
Product code	LON
Device class	Class II
Decision date	May 25, 2006
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 FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE

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