510(k) K232756

Colibrí by Copan Wasp Srl — Product Code LON

K232756 is an FDA 510(k) premarket notification submitted by Copan Wasp Srl for the device "Colibrí". The FDA issued a decision of Substantially Equivalent on December 27, 2023. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Copan Wasp Srl has at least 4 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 27, 2023
Date Received: September 8, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class: Class II
Regulation Number: 866.1645
Review Panel: MI
Submission Type

Other clearances for product code LON

K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
K234012 — VITEK COMPACT PRO (March 14, 2025)
K250344 — BD Phoenix Automated Microbiology System (March 6, 2025)
K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) (March 15, 2024)
K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
K232201 — VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus (October 23, 2023)

510(k) K232756

Clearance Details

Device Classification

Other clearances by Copan Wasp Srl

Other clearances for product code LON

FDA data resources