Atlas FDA

Colibrí System

FDA 510(k) clearance K220546 · decided 2022-10-05

Clearance details

K-number
K220546
Device name
Colibrí System
Applicant
Copan Wasp Srl
Decision
Substantially Equivalent
Date received
2022-02-25
Decision date
2022-10-05
Days to decision
222 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Brescia, IT
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.