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FDA 510(k)

BD Phoenix™ Automated Microbiology System

K-Number: K250344 · 2025-03-06

ApplicantBecton, Dickinson and Company
Decision Date2025-03-06
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Phoenix™ Automated Microbiology System is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K250344. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Phoenix™ Automated Microbiology System?

BD Phoenix™ Automated Microbiology System is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K250344.

When did BD Phoenix™ Automated Microbiology System receive FDA 510(k) clearance?

BD Phoenix™ Automated Microbiology System received FDA 510(k) clearance on 2025-03-06, under 510(k) number K250344.

Who is the listed applicant for BD Phoenix™ Automated Microbiology System?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Phoenix™ Automated Microbiology System?

The FDA product code for BD Phoenix™ Automated Microbiology System is LON.

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Related Devices (Code: LON)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUXK251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and CompanyK250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and CompanyK234012VITEK COMPACT PRObioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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