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 Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K073561
Device Name DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
Applicant
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Applicant Contact HELEN M LEE
Correspondent
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Correspondent Contact HELEN M LEE
Regulation Number866.5510
Classification Product Code
CFN  
Subsequent Product Codes
JIX   JJY  
Date Received12/19/2007
Decision Date 02/26/2008
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
-
-