510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193138Substantially Equivalent

Colibri System

Copan WASP, Brescia, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193138 is the FDA 510(k) clearance record for Colibri System, a class II device, cleared for Copan Wasp Srl on under FDA product code QQV (Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry). FDA's definition for product code QQV reads: "An automated in vitro diagnostic system to prepare colonies of microorganisms grown on solid culture media from human specimens for qualitative identification and differentiation using matrix-assisted laser desorption/ionization-time of...". FDA records list 5 510(k) clearances for Copan Wasp Srl, from to . As of , FDA records show no recalls naming K193138.

Clearance record

Decision date
Received
(775 days to decision)
Product code
QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Regulation
21 CFR 866.3378
Device class
Class II
Review panel
Microbiology
Applicant
Copan Wasp Srl Via F. Perotti 18, Brescia, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QQV

Trailing 12 months

FDA records hold no clearances under product code QQV in the trailing twelve months.

FDA records show no clearances under product code QQV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QQV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260