Cleared Traditional

Colibr?

K232756 · Copan Wasp Srl · Microbiology

Dec 2023

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K232756 is an FDA 510(k) clearance for the Colibr?, 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 December 27, 2023, 110 days after receiving the submission on September 8, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K232756 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2023
Decision Date	December 27, 2023
Days to Decision	110 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