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 System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
510(k) Number K232756
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
Regulation Number866.1645
Classification Product Code
LON  
Subsequent Product Codes
QBN   QQV  
Date Received09/08/2023
Decision Date 12/27/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-