Name: Predicase
Price: 199 USD

K-number	K214122
Device name	BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
Applicant	Becton, Dickinson and Company
Product code	PCI
Device class	Class II
Decision date	Jul 28, 2022
Decision	Substantially Equivalent
Regulation	866.3990

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Source

View the full FDA submission: accessdata.fda.gov

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BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel

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