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510(k) Data Aggregation

K Number

Device Name

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

Manufacturer

Becton, Dickinson and Company

Date Cleared

2025-08-08

(66 days)

Product Code

Regulation Number

Type

Panel

Microbiology (MI)

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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