Name: Predicase
Price: 199 USD

K-number	K050191
Device name	MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
Applicant	Becton, Dickinson & CO
Product code	PER
Device class	Class I
Decision date	Feb 22, 2005
Decision	Substantially Equivalent
Regulation	862.2750

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Source

View the full FDA submission: accessdata.fda.gov

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MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE

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