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 K963116
Device Name UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
Applicant
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK, R.T.B.SC.
Correspondent
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK, R.T.B.SC.
Regulation Number862.1415
Classification Product Code
JMO  
Date Received08/12/1996
Decision Date 08/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-