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510(k) K193138

Colibri System by Copan Wasp Srl — Product Code QQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2021
Date Received
November 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Device Class
Class II
Regulation Number
866.3378
Review Panel
MI
Submission Type

An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS).

Other clearances by Copan Wasp Srl

  • K251511 — PhenoMATRIX (January 22, 2026)
  • K232756 — Colibrí (December 27, 2023)
  • K223245 — Colibrí (March 20, 2023)
  • K220546 — Colibrí System (October 5, 2022)

Other clearances for product code QQV

  • K222563 — BD Kiestra IdentifA (August 31, 2023)
  • K223245 — Colibrí (March 20, 2023)
  • K191964 — BD Kiestra IdentifA (November 3, 2021)