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 Bathophenanthroline, Colorimetry, Iron (Non-Heme)
510(k) Number K854305
Device Name DART IRON & IRON BINDING CAPACITY REAGENT
Applicant
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Applicant Contact RICHARD-JONES
Correspondent
Coulter Electronics, Inc.
440 W. 20 St.
Hialeah,  FL  33010
Correspondent Contact RICHARD-JONES
Regulation Number862.1410
Classification Product Code
CFM  
Date Received10/25/1985
Decision Date 11/12/1985
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
-
-