Name: Predicase
Price: 199 USD

K-number	K033889
Device name	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE
Applicant	Becton, Dickinson & CO
Product code	LON
Device class	Class II
Decision date	Feb 3, 2004
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 CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE

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