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 Test, Antigen, Nuclear, Epstein-Barr Virus
510(k) Number K040120
Device Name DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
Applicant
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Applicant Contact DAVID M IKEDA
Correspondent
DiaSorin, Inc.
1951 Northwestern Ave.
P.O. Box 285
Stillwater,  MN  55082
Correspondent Contact DAVID M IKEDA
Regulation Number866.3235
Classification Product Code
LLM  
Subsequent Product Code
LSE  
Date Received01/20/2004
Decision Date 04/29/2005
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
-
-