FDA 510(k)

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

K-Number: K251713 · 2025-08-08

Decision Date2025-08-08

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) 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 2025-08-08 under 510(k) number K251713. 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 - GN Eravacycline (0.125-2 µg/mL)?

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K251713.

When did BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) receive FDA 510(k) clearance?

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K251713.

Who is the listed applicant for BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)?

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 - GN Eravacycline (0.125-2 µg/mL)?

The FDA product code for BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) is LON.

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Related Devices (Code: LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and Company

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.