510(k) K223245

Device: Colibrí
Applicant: Copan Wasp Srl
510(k) number: K223245
Product code: QQV
Decision: Substantially Equivalent (SESE)
Decision date: 2023-03-20
Date received: 2022-10-20
Regulation: 866.3378
Classification name: Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K222563	BD Kiestra IdentifA	Becton, Dickinson and Company	2023-08-31
K193138	Colibri System	Copan Wasp Srl	2021-12-27
K191964	BD Kiestra IdentifA	Becton, Dickinson and Company	2021-11-03