510(k) K193138

Device: Colibri System
Applicant: COPAN WASP S.r.l.
510(k) number: K193138
Product code: QQV
Decision: Substantially Equivalent (SESE)
Decision date: 2021-12-27
Date received: 2019-11-13
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#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
58050148218208	Colibrí™	COPAN WASP SRL	2022-11-15
58052870818435	Colibrí™ Preparation Station	COPAN WASP SRL	2022-01-27
58052870818428	Colibrí™ Vision System	COPAN WASP SRL	2022-01-27
58052870816202	Colibrí™ System	COPAN WASP SRL	2022-01-27

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K222563	BD Kiestra IdentifA	Becton, Dickinson and Company	2023-08-31
K223245	Colibrí	Copan Wasp Srl	2023-03-20
K191964	BD Kiestra IdentifA	Becton, Dickinson and Company	2021-11-03

summary

Decision Summary