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 Ferritin, Antigen, Antiserum, Control
510(k) Number K193650
Device Name LIAISON Ferritin
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Applicant Contact John C. Walter
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
Stillwater,  MN  55082
Correspondent Contact Mari Meyer
Regulation Number866.5340
Classification Product Code
DBF  
Date Received12/30/2019
Decision Date 09/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-