Name: Predicase
Price: 199 USD

K-number	K250358
Device name	BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
Applicant	Becton, Dickinson and Company
Product code	PCI
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	866.3990

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System

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