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510(k) K250447

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) by Becton, Dickinson and Company — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2025
Date Received
February 18, 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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  • K230864 — VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptom (July 5, 2023)
  • K222378 — VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) (June 26, 2023)