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510(k) K220546

Colibrí System by Copan Wasp Srl — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2022
Date Received
February 25, 2022
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

Other clearances by Copan Wasp Srl

  • K251511 — PhenoMATRIX (January 22, 2026)
  • K232756 — Colibrí (December 27, 2023)
  • K223245 — Colibrí (March 20, 2023)
  • K193138 — Colibri System (December 27, 2021)

Other clearances for product code LON

  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (March 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (March 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • 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)