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 Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K112996
Device Name EUROIMMUN ANTI-ENA POOL ELISA (IGG)
Applicant
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Correspondent Contact KATHRYN KOHL
Regulation Number866.5100
Classification Product Code
LLL  
Date Received10/07/2011
Decision Date 04/09/2013
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
-
-