Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
510(k) Number K223245
Device Name Colibrí
Applicant
Copan WASP Srl
Via A. Grandi, 32
Brescia,  IT 25125
Applicant Contact Giovanna Catalano
Correspondent
Copan WASP Srl
Via A. Grandi, 32
Brescia,  IT 25125
Correspondent Contact Chiara Congiu
Classification Product Code
QQV  
Subsequent Product Codes
LON   QBN  
Date Received10/20/2022
Decision Date 03/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-