Colibrí

FDA 510(k) K232756 · Copan Wasp Srl

Substantially Equivalent

510(k) numberK232756

Submission

Device name
Colibrí
Applicant
Copan Wasp Srl
Brescia, IT
Received
September 8, 2023
Decision date
December 27, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1645
Specialty
Microbiology

Other 510(k)s with product code LON

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K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional bioMerieux, Inc.04/15/2026SE
K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional Biomerieux03/26/2026SE
K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional bioMerieux, Inc.08/21/2025SE
K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional Becton, Dickinson and Company08/08/2025SE
K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)LON · Traditional Becton, Dickinson and Company05/19/2025SE
K234012Vitek Compact ProLON · Traditional bioMerieux, Inc.03/14/2025SE
K250344BD Phoenix™ Automated Microbiology SystemLON · Special Becton, Dickinson and Company03/06/2025SE
K233986BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)LON · Traditional Becton, Dickinson and Company03/15/2024SE
K234000VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional bioMerieux, Inc.03/11/2024SE
K232201VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus…LON · Traditional bioMerieux, Inc.10/23/2023SE

More from bioMerieux, Inc.

510(k)DeviceDecision
K251511PhenoMATRIXPPU · Traditional 01/22/2026SE
K223245ColibríQQV · Traditional 03/20/2023SE
K220546Colibrí SystemLON · Traditional 10/05/2022SE
K193138Colibri SystemQQV · Traditional 12/27/2021SE

Questions and answers

When was Colibrí cleared by the FDA?

Colibrí (K232756) received a 510(k) decision of Substantially Equivalent on December 27, 2023, 110 days after the submission was received.

What is the product code of K232756?

The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.