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 Culture Media, Non-Propagating Transport
510(k) Number K180052
Device Name UriSwab-Urine Collection, Transport and Preservation System
Applicant
Copan Italia Spa
Via F. Perotti 10
Brescia,  IT 25125
Applicant Contact Elisabetta Zanella
Correspondent
Melissa M. Traylor
4133 Mayfield St.
Santa Maria,  CA  93455
Correspondent Contact Melissa M Traylor
Regulation Number866.2390
Classification Product Code
JSM  
Subsequent Product Code
LIO  
Date Received01/08/2018
Decision Date 03/23/2018
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
-
-