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 System, Test, Rheumatoid Factor
510(k) Number K024067
Device Name RHEUMATOID FACTOR (RF)
Applicant
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number866.5775
Classification Product Code
DHR  
Date Received12/10/2002
Decision Date 01/15/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-