• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name ferritin, antigen, antiserum, control
510(k) Number K935528
Device Name DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH
Original Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
p.o. box 80022
wilmington,  DE  19880
Original Contact rebecca s ayash
Regulation Number866.5340
Classification Product Code
DBF  
Date Received11/16/1993
Decision Date 01/28/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-