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 Ferrozine (Colorimetric) Iron Binding Capacity
510(k) Number K994115
Device Name TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact ROBIN O NORRIS
Correspondent
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact ROBIN O NORRIS
Regulation Number862.1415
Classification Product Code
JMO  
Date Received12/06/1999
Decision Date 01/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-