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 System, Test, Beta-2-Microglobulin Immunological
510(k) Number K083463
Device Name DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
Applicant
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714 -6101
Applicant Contact ANNA M KATHLEEN ENNIS
Correspondent
Siemens Healthcare Diagnostics
500 Gbc Dr.
P.O. Box 6101
Newark,  DE  19714 -6101
Correspondent Contact ANNA M KATHLEEN ENNIS
Regulation Number866.5630
Classification Product Code
JZG  
Subsequent Product Codes
JIX   JJY  
Date Received11/24/2008
Decision Date 03/13/2009
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
Recalls CDRH Recalls
-
-