Home / 510(k) Clearances / K233986

510(k) K233986

BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) by Becton, Dickinson and Company — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
December 18, 2023
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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  • K232756 — Colibrí (December 27, 2023)
  • K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus (October 23, 2023)
  • 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)