Name: Predicase
Price: 199 USD

K-number	K060214
Device name	BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML
Applicant	Becton, Dickinson & CO
Product code	LON
Device class	Class II
Decision date	Mar 9, 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 MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML

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