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 Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K050625
Device Name VARELISA RECOMBI ANA PROFILE, MODEL 18496
Applicant
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Applicant Contact SABINE KLUGBAUER
Correspondent
Sweden Diagnostics (Germany) GmbH
Munzingerstrasse 7
Freiburg,  DE D-79111
Correspondent Contact SABINE KLUGBAUER
Regulation Number866.5100
Classification Product Code
LJM  
Date Received03/11/2005
Decision Date 04/26/2005
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
-
-