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 photometric method, iron (non-heme)
510(k) Number K060264
Device Name DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Applicant Contact ANDREA M TASKER
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Correspondent Contact ANDREA M TASKER
Regulation Number862.1410
Classification Product Code
JIY  
Date Received02/01/2006
Decision Date 03/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-