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 a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2025-08-08 under approval 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. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K251713.

When was BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) approved by the FDA?

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

What company makes 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 manufactured by Becton, Dickinson and Company.

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)

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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.