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

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System

Becton, Dickinson And Company

The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Max Enteric Bacterial Panel, Bd Max Extended Enteric Bacterial Panel.

Pre-market Notification Details

Device IDK214122
510k NumberK214122
Device Name:BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
ClassificationGastrointestinal Bacterial Panel Multiplex Nucleic Acid-based Assay System
Applicant Becton, Dickinson And Company 7 Loveton Circle Sparks,  MD  21152
ContactJoseph Basore
CorrespondentJoseph Basore
Becton, Dickinson And Company 7 Loveton Circle Sparks,  MD  21152
Product CodePCI  
Subsequent Product CodeOOI
Subsequent Product CodePCH
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-30
Decision Date2022-07-28

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