Home / 510(k) Clearances / K251713

510(k) K251713

BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) by Becton, Dickinson and Company — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2025
Date Received
June 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type

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Other clearances for product code LON

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