Cleared Traditional

Colibr? System

K220546 · Copan Wasp Srl · Microbiology

Oct 2022

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K220546 is an FDA 510(k) clearance for the Colibr? System, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on October 5, 2022, 222 days after receiving the submission on February 25, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K220546 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2022
Decision Date	October 05, 2022
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1645