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 Hepatitis A Test (Antibody And Igm Antibody)
510(k) Number K103529
Device Name LIAISON XL ANALYZER MODEL 10050
Applicant
DiaSorin, Inc.
195 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact Mari Meyer
Correspondent
DiaSorin, Inc.
195 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact Mari Meyer
Regulation Number866.3310
Classification Product Code
LOL  
Subsequent Product Code
JJF  
Date Received12/01/2010
Decision Date 01/21/2011
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
-
-